Last updated: 05/15/2019 07:40:06
To investigate the gastrointestinal behaviour of two triple combination products in healthy male volunteers
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A single dose, open label, randomized scintigraphic study to investigate the gastrointestinal behavior of 2 triple combination products (Acetaminophen, Phenylephrine and Dextromethorphan) in healthy male volunteers
Trial description: This clinical study will be conducted to characterize the gastrointestinal transit of two multi-symptoms formulations by inclusion of a radiolabel marker.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Mean time to onset of gastric emptying
Timeframe: up to 10 hours post drug administration of Day 1
Mean time to complete gastric emptying
Timeframe: up to 10 hours post drug administration of Day 1
Characterize gastrointestinal emptying by measuring GE25% values
Timeframe: up to 10 hours post drug administration of Day 1
Characterize gastrointestinal emptying by measuring GE50% values
Timeframe: up to 10 hours post drug administration of Day 1
Characterize gastrointestinal emptying by measuring GE90% values
Timeframe: up to 10 hours post drug administration of Day 1
Amount of drug remaining in the stomach after administration at different timepoints
Timeframe: up to 10 hours post drug administration of Day 1
Sectional areas under the gastric emptying curve and Total AUC
Timeframe: up to 10 hours post drug administration of Day 1
Total Area under the curve (AUC)
Timeframe: up to 10 hours post drug administration of Day 1
Gastric emptying t half (t-1/2) value
Timeframe: up to 10 hours post drug administration of Day 1
Small intestinal transit time
Timeframe: up to 10 hours post drug administration of Day 1
Secondary outcomes:
Safety (Adverse events Monitoring)
Timeframe: From Screening, to 5 days following last administration of investigational product
Safety (Laboratory Evaluations)
Timeframe: At Baseline and Day 1
Interventions:
Enrollment:
28
Primary completion date:
2018-29-03
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Common cold
Product
dextromethorphan, paracetamol, paracetamol/dextromethorphan/phenylephrine, phenylephrine
Collaborators
Not applicable
Study date(s)
March 2018 to March 2018
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
21 - 45 years
Accepts healthy volunteers
Yes
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study before any assessment is performed.
- Healthy male participants who, at the time of screening, are between the ages of 21 and 45 years, inclusive.
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
Inclusion and exclusion criteria
Inclusion criteria:
- Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study before any assessment is performed.
- Healthy male participants who, at the time of screening, are between the ages of 21 and 45 years, inclusive.
- Participants who are willing and able to comply with scheduled visits, treatment plan, bio-imaging procedure, laboratory tests and other study procedures.
- Healthy participant which is defined as in general good physical health, as judged by the investigator and no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead Electrocardiogram (ECG) or clinical laboratory tests.
- Body Mass Index (BMI) of 17.5 to 30.5 kilogram per meter square (kg/m2); and a total body weight >50 kg (110 lbs)
Exclusion criteria:
- Participants who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or participants who are GSK employees directly involved in the conduct of the study.
- Participation in other studies involving investigational drug(s) within 30 days prior to study entry and/or during study participation.
- Acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
- Known or suspected intolerance or hypersensitivity or contraindication to the study materials (or closely related compounds) or any of their stated ingredients.
- Participant with known allergy or intolerance to any of the contents of the standard meals.
- Participant is vegetarian.
- Unwilling or unable to comply with the Lifestyle guidelines described in this protocol.
- Use of prescription or non-prescription drugs and dietary supplements within 14 days or 5 half-lives, whichever is longer, prior to the first dose of investigational product that are deemed by the investigator to have a potential impact on the study objectives results.
- Evidence or history of clinically significant laboratory abnormality, hematological, renal, endocrine, pulmonary, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease within the last 5 years that may increase the risk associated with study participation.
- A positive urine drug screen, breath alcohol test or urine cotinine test during Screening or on Day -1 of the study.
- Any condition possibly affecting drug absorption (e.g., gastrectomy)
- A history of current or relevant previous non-self-limiting gastrointestinal disorders peptic ulcer disease and/or gastrointestinal bleeding.
- Currently suffering from disease known to impact gastric emptying, e.g. migraine, insulin-dependent diabetes mellitus.
- The participant has had radiation exposure from clinical trials, including from the present study, and from therapeutic or diagnostic exposure, but excluding background radiation, exceeding a target organ (colon) dose of 50 mSv (5 rems) from a single dose within the last 30 days or a cumulative dose of 150 mSv (15 rems) in the last 12 months. No participant whose occupation requires monitoring for radiation exposure will be enrolled in the study.
- Participants who have been exposed to ionising radiation in excess of 10 mSv (whole body effective dose) above background over the previous 3 years period as a result of occupational exposure or previous participation in research studies. Clinically justified (therapeutic or diagnostic) exposures are not included in this calculation.
- Renal disease or impaired renal function at screening as indicated by abnormal levels of serum creatinine or urea or the presence of clinically significant abnormal urinary constituents (e.g. albuminuria). Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance.
- History or current evidence of ongoing hepatic disease or impaired hepatic function at screening. A candidate will be excluded if more than one of the following lab value deviations are found: 1) AST/SGOT (≥ 1.2 ULN), ALT/SGPT (≥ 1.2 ULN), 2) GGT (≥ 1.2 ULN), ALP (≥ 1.2 ULN), 3) total bilirubin (≥ 1.2 mg/dL) Minor deviations of laboratory values from the normal range are permitted, if judged by the investigator to have no clinical relevance. Positive results in any of the virology tests for HIV-Ab, HCV-Ab, HBsAg and HBc-Ab (Total).
- Diagnosis of long QT syndrome or QTc > 450 msec for males at screening.
- Participants who were intending to father a child in the 3 months following the study.
- Participants who were unwilling to follow contraception requirements
- Participant had any non-removable metal objects such as metal plates, screws etc. in their chest or abdominal area.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of Screening.
- Smokers defined as the use of tobacco products (including but not limited to: electronic-cigarettes, nicotine gums, nicotine lozenges, etc) during the 6 months prior to screening or a positive urine cotinine test at screening.
- Participant has consumed (eat or drink) grapefruit or grapefruit-related citrus fruits (e.g., Seville oranges, pomelos, pawpaw, dragon fruit, kiwi fruit, mango, passion fruit, pomegranate, rambutan, star fruit or products that contain these fruits) 14 days prior to the first dose of investigational product.
- Participants who have previously been enrolled in this study.
Trial location(s)
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40504
Status
Study Complete
Study documents
Statistical analysis plan
Available language(s): English
Protocol
Available language(s): English
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
2018-29-03
Actual study completion date
2018-29-03
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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