Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat

PHASE1CompletedINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

July 8, 2019

Primary Completion Date

August 26, 2019

Study Completion Date

August 26, 2019

Conditions
Cholestasis
Interventions
DRUG

Linerixibat tablet

Linerixibat will be available as white to slightly colored film-coated round tablet to be administered as two tablets taken in the fasted state in the morning with 240 milliliter (mL) of room temperature water.

DRUG

[14C]-linerixibat intravenous infusion

\[14C\]-linerixibat will be available as clear, colorless solution free from visible particulates to be administered 25 mL IV over 3 hours immediately after the oral dose.

DRUG

Linerixibat oral solution

Linerixibat will be available as clear, colorless solution free from visible particulates to be administered 60 mL solution in the fasted state in the morning.

Trial Locations (1)

NW10 7EW

GSK Investigational Site, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT03992014 - Pharmacokinetics (PKs) and Metabolism of Radiolabelled Linerixibat | Biotech Hunter | Biotech Hunter