Last updated: 07/17/2024 17:29:55

Study of safety and drug levels of CCI15106 inhalation powder in healthy adults and adults with moderate chronic obstructive pulmonary disease. Study of CCI15106 levels in people standing near the person inhaling the drug

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GSK study ID
205822
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Clinicaltrials.gov ID
NCT03235726
See results summary
EudraCT ID
2017-001070-42
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A double-blind (sponsor unblind), randomized, placebo-controlled, single and repeat escalating dose study to investigate the safety, tolerability, and pharmacokinetics of CCI15106 inhalation powder in healthy participants and participants with moderate chronic obstructive pulmonary disease (COPD) including evaluation of environmental and healthy by-stander exposure levels during dosing
Trial description: This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:

Number of subjects with adverse events (AEs) and serious AEs (SAEs): Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with AEs, SAEs: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with AEs, SAEs: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with AEs, SAEs: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal clinical chemistry findings: Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with abnormal clinical chemistry findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal clinical chemistry findings: Cohort A Part 2

Timeframe: Up to day 32

Number of subjects with abnormal clinical chemistry findings: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal hematology findings: Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with abnormal clinical hematology findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal clinical hematology findings: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with abnormal clinical hematology findings: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal urinalysis findings: Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with abnormal urinalysis findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal urinalysis findings: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with abnormal urinalysis findings: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal electrocardiogram (ECG) findings: Cohort A Part 1

Timeframe: Up to day 52

Number of subjects with abnormal ECG findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal ECG findings: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with abnormal ECG findings: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal telemetry findings: Cohort A Part 1

Timeframe: Up to Day 18

Number of subjects with abnormal telemetry findings: Cohort B part 1

Timeframe: Up to Day 13

Number of subjects with abnormal telemetry findings: Cohort A Part 2

Timeframe: Day 1

Number of subjects with abnormal telemetry findings: Cohort B Part 2

Timeframe: Up to Day 13

Number of subjects with abnormal spirometry findings: Cohort A Part 1

Timeframe: Up to Day 19

Number of subjects with abnormal spirometry findings: Cohort B Part 1

Timeframe: Up to Day 14

Number of subjects with abnormal spirometry findings: Cohort A Part 2

Timeframe: Day 1

Number of subjects with abnormal spirometry findings: Cohort B Part 2

Timeframe: Up to Day 14

Number of subjects with abnormal body temperature findings: Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with abnormal body temperature findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal body temperature findings: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with abnormal body temperature findings: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal pulse rate findings: Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with abnormal pulse rate findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal pulse rate findings: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with abnormal pulse rate findings: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal respiratory rate findings: Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with abnormal respiratory rate findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal respiratory rate findings: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with abnormal respiratory rate findings: Cohort B Part 2

Timeframe: Up to Day 45

Number of subjects with abnormal blood pressure findings: Cohort A Part 1

Timeframe: Up to Day 52

Number of subjects with abnormal blood pressure findings: Cohort B-C Part 1

Timeframe: Up to Day 45

Number of subjects with abnormal blood pressure findings: Cohort A Part 2

Timeframe: Up to Day 32

Number of subjects with abnormal blood pressure findings: Cohort B Part 2

Timeframe: Up to Day 45

Area under the curve (AUC) from time zero to the time of last quantifiable concentration (AUC[o-last]) of CCI15106: single dose in Part 1 and 2

Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)

Maximum observed concentration (Cmax) of CCI15106: single dose in Part 1 and 2

Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)

Time required to reach Cmax (Tmax) of CCI15106: single dose in Part 1 and 2

Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)

AUC from time zero to infinity (AUC[o-inf]) of CCI15106: single dose Part 1 and 2

Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)

Elimination half-life (t1/2) of CCI15106: single dose Part 1 and 2

Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)

Clearance (CL/F) of CCI15106: single dose Part 1 and 2

Timeframe: Pre-dose, and 0.25, 0.5, 0.75, 1, 2, 4, 6, 8, 10, and 12 hours post-dose on Day 1 (Cohort A Parts 1 and 2) and Day 3 (Cohort A Part 1); 24 hours after Day 1 dose (Cohort A Parts 1 and 2)

AUC from time zero to end of dosing interval (AUC[o-tau]) of CCI15106: repeat dose Part 1 and 2

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)

Cmax of CCI15106: repeat dose Part 1 and 2

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)

Tmax of CCI15106: repeat dose Part 1 and 2

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)

T1/2 of CCI15106: repeat dose Part 1 and 2

Timeframe: Pre-dose, 0.25, 0.5, 0.75, 1,2,4,6,8,10 and 12 hours on Days 6,19 (Cohort A Part 1) and on Days 1,14 (Cohort B Part 1,2); Pre-dose on Days 7, 9, 11, 13, 15, 17, 20, 21, 22 (Cohort A Part 1); Pre-dose on Days 2, 4, 6, 8, 10, 12, 15 (Cohort B Part 1,2)

Concentration of CCI15106 in plasma of bystanders: Cohort C Part 1

Timeframe: Pre-dose, 15 minutes post-dose on Days 1, 7, 14 and anytime on Day 15

Amount of CCI15106 accumulated on filters fitted on stationary pumps: Part 1

Timeframe: Up to Day 14

Amount of CCI15106 accumulated on filters fitted on bystanders: Part 1

Timeframe: Up to Day 14

Secondary outcomes:

Concentration of CCI15106 in lung epithelial lining fluid (ELF): Cohort B Part 1

Timeframe: On Day 10,11,12,or 13

Concentration of CCI15106 in lung epithelial lining fluid (ELF): Cohort B Part 2

Timeframe: On Day 10,11,12,or 13

Number of medical device incidents: Cohort A Part 1

Timeframe: Up to Day 19

Number of medical device incidents: Cohort B Part 1

Timeframe: Up to Day 14

Number of medical device incidents: Cohort A Part 2

Timeframe: Day 1

Number of medical device incidents: Cohort B Part 2

Timeframe: Up to Day 14

Interventions:
  • Drug: CCI15106
  • Drug: Placebo
    • Enrollment:
    52
    Primary completion date:
    2018-19-06
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Etienne Dumont, Amanda Oliver, Chris Ioannou, Julia Billiard, Jeremy Dennison, Frans Van Den Berg, Shuying Yang, Vijaya Chandrasekaran, Graeme Young, Anirban Lahiry, Dave Starbuck, Andy Harrell, Alex Georgiou, Nathalie Hopchet, Andy Gillies, Steve Baker .Phase I studies evaluating safety, tolerability, and pharmacokinetics of an inhaled dry-powder formulation containing ribavirin in healthy participants and those with COPD .Antimicrob Agents Chemother.2020;64(5) DOI: 10.1128/AAC.02267-19 PMID: 32071044
    Medical condition
    Pulmonary Disease, Chronic Obstructive
    Product
    ribavirin
    Collaborators
    Not applicable
    Study date(s)
    July 2017 to June 2018
    Type
    Interventional
    Phase
    1

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 75 years
    Accepts healthy volunteers
    Yes
    • Some important Inclusion Criteria:
    • For healthy subjects and bystanders:
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Some important Inclusion Criteria: For healthy subjects and bystanders:
    • 18 to 65 years of age.
    • Healthy as determined by a doctor.
    • Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
    • Women who are not pregnant or breastfeeding, and not of childbearing potential. For subjects with COPD:
    • 40 to 75 years of age.
    • Diagnosed with moderate COPD by a doctor.
    • Have breathing test results that are consistent with moderate COPD as defined in the study protocol.
    • A smoker or an ex-smoker.
    • Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
    • Women who are not pregnant or breastfeeding, and not of childbearing potential. Some Important Exclusion Criteria: For healthy subjects and bystanders:
    • History of liver disease.
    • Use of over-the-counter or prescription drugs (including vitamins) 7 days before the study until completion of the follow-up visit.
    • Participation in the study would result in loss of more than 500 milliliter (mL) of blood within 3 months.
    • Participation in another clinical trial with an investigational product within about 3 months before this study.
    • Positive drug/alcohol screen.
    • Regular use of known drugs of abuse.
    • Regular alcohol consumption within 3 months before the study.
    • Breath test indicative of smoking at study start.
    • Documented lactose allergy/intolerance.
    • Men whose partner is pregnant or breastfeeding cannot participate.
    • Certain blood test results may not allow subjects to participate, as described in the study protocol. For subjects with COPD:
    • History of liver disease.
    • Poorly controlled COPD disease as, for example, more than 2 exacerbations of COPD per year.
    • Some respiratory conditions, like for example active tuberculosis, lung cancer or any other respiratory condition. Subjects with other respiratory conditions (for example, clinically significant: asthma, pulmonary fibrosis, bronchiectasis) are excluded if these conditions are the primary cause of their respiratory symptoms.
    • Unstable or uncontrolled cardiac disease.
    • Problems with kidney function as defined in the study protocol.
    • Past or current medical conditions or diseases that are not well controlled.
    • Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening and for the duration of the study.
    • Subjects taking medications for any chronic conditions have to be on stable doses for 4 weeks before screening and until after study treatment is finished.
    • Use of short-acting inhaled bronchodilators is allowed, but subjects must be able to stop their medications several times during the study.
    • Use of long-acting bronchodilators is allowed, but subjects must be able to change the schedule of their medications twice during the study.
    • Participation in the study would result in loss of more than 500 mL within 3 months.
    • Participation in another clinical trial with an investigational product within about 3 months before this study.
    • Positive drug/alcohol screen.
    • Regular use of known drugs of abuse.
    • Regular alcohol consumption within 3 months before the study.
    • Unable to refrain from smoking for certain periods during the study (maximum about 6 hours).
    • Documented lactose allergy/intolerance.
    • Men whose partner is pregnant or breastfeeding cannot participate.
    • Certain blood test results may not allow subjects to participate, as described in the study protocol.

    Trial location(s)

    Location
    Status
    Contact us
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    Location
    GSK Investigational Site
    Park Royal, London, United Kingdom, NE10 7EW
    Status
    Study Complete
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    Study documents

    Clinical study report
    Available language(s): English
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    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    Actual primary completion date
    2018-19-06
    Actual study completion date
    2018-19-06

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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