Last updated: 07/15/2024 16:40:07
Validation Study for the Comparison of Ambrisentan Concentrations Using Venous Blood Sampling and Capillary Micro Sampling Methods
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: An Open-Label, Single Dose Study to Compare Ambrisentan (GSK1325760) Concentrations Determined Using Venous Blood Sampling and Capillary Micro Sampling Methods in Healthy Adult Participants
Trial description: This is an open-label, single dose, single centre study in healthy adult participants to compare ambrisentan (GSK1325760) concentrations determined using capillary micro sampling and venous blood sampling methods. Parallel PK samples will be collected at the same sampling time point from the same subject for the comparison of the two methods. Specifically, sampling methods for comparison are (i) the venous sample collection used in all historic studies with ambrisentan versus (ii) capillary micro sampling collection using the Tasso M20 device.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Proportion of Participants of Relative Percentage Difference in Plasma Concentration for Each Participant at Each Timepoint
Timeframe: 1, 2, 3, 4, 8, 12, 24, 48, 72 hours post dose
Secondary outcomes:
The Average In-Vivo Blood/Plasma Ratio for Each Participant
Timeframe: 1, 2, 3, 4, 8, 12, 24, 48, 72 hours post dose
Interventions:
Drug: Ambrisentan
Enrollment:
12
Observational study model:
Other
Primary completion date:
2023-06-11
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Hypertension, Pulmonary
Product
ambrisentan
Collaborators
Not applicable
Study date(s)
September 2023 to November 2023
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 65 Years
Accepts healthy volunteers
Yes
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring.
- Average systolic blood pressure between 100-160 mmHg and diastolic between 55-90 millimetres of mercury (mmHg) (inclusive) over 3 readings at screening.
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Haemoglobin (Hb) below the normal range (Hb [130-170] gram/Litre (g/L) for male participants; and Hb [115-155] g/L for female participants).
Inclusion and exclusion criteria
Inclusion criteria:
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring.
- Average systolic blood pressure between 100-160 mmHg and diastolic between 55-90 millimetres of mercury (mmHg) (inclusive) over 3 readings at screening.
- Body weight greater than (>) 50-kilogram (kg) for men and greater than or equal to (≥) 45kg for women, and body mass index (BMI) within the range 18-32 kilograms per square meter (kg/m2) (inclusive).
- Male participants are eligible to participate if they agree to the following during the study and for at least 94 days after study intervention corresponding to time needed to eliminate study intervention plus an additional 90 days (a spermatogenesis cycle) and refrain from donating sperm. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle and Must agree to use contraception/barrier.
- Female participant of non-childbearing potential (WONCBP)
- Participants of age > 50, who have completed an approved SARS-CoV-2 vaccine course.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion criteria:
- History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Haemoglobin (Hb) below the normal range (Hb [130-170] gram/Litre (g/L) for male participants; and Hb [115-155] g/L for female participants).
- Alanine transaminase (ALT) >1.5x upper limit of normal (ULN)
- Aspartate transaminase (AST) >1.5x upper limit of normal (ULN)
- Total bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent (%)
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
- QTcF >450 millisecond (msec)
- Signs and symptoms suggestive of COVID-19.
- Past or intended use of over the counter or prescription medication (including vitamins and dietary or herbal supplements but excluding paracetamol (2 g/day) within 7 days (or 14 days if the drug is a potential enzyme inhibitor) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless approved by the Investigator in conjunction with GSK Medical Monitor. Participation in the study would result in loss of blood or blood products in excess of 500 millilitre (mL) within a 56-day period.
- The participant has participated, or is currently enrolled, in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Presence of Hepatitis B surface antigen (HBsAg) at screening.
- Positive Hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention
- Positive Hepatitis C ribonucleotide (RNA) test result at screening or within 3 months prior to first dose of study intervention.
- Positive pre-study drug/alcohol screen, including tetrahydrocannabinol (THC)
- Positive human immunodeficiency virus (HIV) antibody test
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening] OR [Carbon monoxide levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening Current drug abuse or dependence (including tetrahydrocannabinol), or a history of drug abuse or dependence within a year prior to Day 1.
- Regular use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to “vape”.
- Sensitivity to any of the study interventions, or components (which include lactose and soya among others) thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- Use of any products intended to treat medical conditions that are not approved by the governing health authority in a given country or region (for example, herbal medicine, health supplements, traditional medicine, homeopathic remedies, etc.).
Trial location(s)
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
2023-06-11
Actual study completion date
2023-06-11
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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