Loading clinical trials...

Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants

An Open-label, Randomized Three Period Cross-over Relative Bioavailability Study to Compare the Pharmacokinetic Parameters of a Lower Dose Formulation of Ambrisentan (GSK1325760) With Marketed Ambrisentan in Healthy Adult Participants

NCT04095286•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

This is a single center, open-label, randomized, single-dose, three-period cross-over study in healthy participants. The aim of this study is to provide clinically relevant information on the pharmacokinetic (PK) and safety profile of a new lower dose formulation ambrisentan (AMB) tablet, which is intended for pediatric use. The study will compare the relative bioavailability of the lower dose tablet, dispersed in water and administered orally, with the reference marketed AMB tablet in healthy adults. The total study duration for each participant is expected to be approximately 9 weeks.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Participants must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
•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 millimeter of mercury (mmHg) and diastolic between 55-90 mmHg (inclusive) over 3 readings at Screening.
•Body weight \>=50 kilogram (kg) for men and \>= 45kg for women, and body mass index (BMI) within the range 18-30 kilogram per meter square (kg/m\^2) (inclusive).
•Male participants are eligible to participate if they agree to the following during the study and for at least 13 weeks afterwards corresponding to time needed to eliminate study intervention (5 terminal half-lives) plus an additional 90 days (a spermatogenesis cycle): 1. Refrain from donating sperm plus either 2. Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent. OR
•Must agree to use contraception/barrier, as follows: Agree to use a male condom; and Female partner to use an additional highly effective contraceptive method with a failure rate of \<1% per year as described.
•A female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP).
•Capable of giving signed informed consent.

Exclusion Criteria

•History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,endocrine, hematological, 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.
•History or presence of palpitations or tachyarrhythmia.
•Hemoglobin (Hb) below the normal range (Hb \<133 grams per liter \[g/L\] for male participants ; and Hb \<114 g/L for female participants).
•Alanine transaminase (ALT) \>1.5 times upper limit of normal (ULN)
•Bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
•Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
•Corrected QT interval (QTc) \>450 millisecond (msec).
•Past or intended use of over-the-counter or prescription medication (including vitamins and dietary or herbal supplements but excluding paracetamol \<=2 grams/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 GlaxoSmithKline Medical Monitor.
•Participation in the study would result in loss of blood or blood products in excess of 500 milliliter (mL) within a 56-day period.
•Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
+10 more criteria

Locations (1)

GSK Investigational Site

Cambridge, Cambridgeshire, United Kingdom

Key Dates

Start Date

September 30, 2019

Primary Completion Date

December 17, 2019

Completion Date

December 17, 2019

Last Updated

August 6, 2020

Enrollment

ACTUAL participants

Conditions

Hypertension, Pulmonary

Interventions

AMB new formulation (1 mg)

DRUG

Reference AMB (5 mg)

DRUG

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

NCT07079592

Artificial Intelligence (AI)Artificial Intelligence (AI) in Diagnosis+1 more

View study

RECRUITINGNA

Functional Pulmonary Capillary Surface Area in BPA for CTEPH

NCT05719415

Hypertension, PulmonaryPulmonary Thromboembolisms

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Relative Bioavailability Study of Marketed and Lower Dose Ambrisentan in Healthy Adult Participants

Inclusion Criteria

Exclusion Criteria

A Deep-Learning-Enabled Electrocardiogram for Detecting Pulmonary Hypertension

Functional Pulmonary Capillary Surface Area in BPA for CTEPH

Real-World Study of PADN for the Treatment of PAH

Endtidal Carbon Dioxide for Earlier Detection of Pulmonary Hypertension

A Study to Test the Effects of Riociguat in Patients With Pulmonary Hypertension Associated With Left Ventricular Systolic Dysfunction

A Study of the Efficacy and Safety of Frespaciguat (MK-5475) in Participants With Pulmonary Arterial Hypertension (INSIGNIA-PAH: Phase 2/3 Study of an Inhaled sGC Stimulator in PAH) (MK-5475-007)