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

GlaxoSmithKline Research and Development Ltd0 sites24 target enrollmentJuly 30, 2019

DrugsVolibris

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: GlaxoSmithKline Research and Development Ltd
Enrollment: 24
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 30, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

GlaxoSmithKline Research and Development Ltd

Eligibility Criteria

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the following criteria apply:
•1\. Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent
•2\. Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and cardiac monitoring (refer to Section 5\.4 for information about rescreening).
•3\. Average systolic blood pressure between 100\-160 mmHg and diastolic between 55\-90 mmHg (inclusive) over 3 readings at screening
•4\. Body weight \>50 kg for men and \= 45kg for women, and body mass index (BMI) within the range 18\-30 kg/m2 (inclusive).
•5\. Male or Female
•a. Male Participants
•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):
•?Refrain from donating sperm
•PLUS either:

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•1\. 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
•2\. History or presence of palpitations or tachyarrhythmias
•3\. Haemoglobin (Hb) below the normal range (Hb \<133 g/L for male participants; and Hb \<114 g/L for female participants)
•4\. Alanine transaminase (ALT) \>1\.5x upper limit of normal (ULN)
•5\. Bilirubin \>1\.5xULN (isolated bilirubin \>1\.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
•6\. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
•7\. QTc \>450 msec
•?The QTc is the QT interval corrected for heart rate according to Bazett’s formula (QTcB), Fridericia’s formula (QTcF), and/or another method, machine\-read or manually over\-read.
•?The specific formula that will be used to determine eligibility and discontinuation for an individual subject should be determined prior to initiation of the study. In other words, several different formulae cannot be used to calculate the QTc for an individual subject and then the lowest QTc value used to include or discontinue the subject from the trial.