NCT02801981

A Double-blind, Randomized, Placebo Controlled, Dose Escalating Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Parameters of Single Doses of GSK2330672 in Japanese Healthy Male Volunteers

Completed Phase 1 Last updated 8 November 2016

What this trial tests

Phase 1 trial testing GSK2230672 in Cholestasis in 16 participants. Completed in 1 August 2016.

Timeline

1 June 2016

Primary endpoint
1 August 2016

1 August 2016

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	16
Start date	1 June 2016
Primary completion	1 August 2016
Estimated completion	1 August 2016
Sites	1 location across Japan

Drugs / interventions tested

• GSK2230672 — full drug profile →
• Placebo

Conditions studied

• Cholestasis — all drugs for Cholestasis →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 64, male only, with Cholestasis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of Subjects with Adverse events (AE)
  Time frame: Maximum of 5 weeks
• Safety as assessed by blood pressure
  Time frame: Maximum of 5 weeks
  Systolic and diastolic blood pressure will be measured on Day -1, post dose 2 hours (hrs), 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
• Safety as assessed by heart rate
  Time frame: Maximum of 5 weeks
  Heart rate will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
• Safety as assessed by body temperature
  Time frame: Maximum of 5 weeks
  Body temperature will be measured on Day -1, post dose 2 hrs, 12.5 hrs, 24.5 hrs and at 48 hrs in each period and at follow-up.
• Safety as assessed by clinical chemistry parameters
  Time frame: Maximum of 5 weeks
  Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up
• Safety as assessed by haematology
  Time frame: Maximum of 5 weeks
  Blood sample will be collected on Day -1, at 48 hrs in each period and at follow-up

Sponsor's own description

This study will be the first to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled, dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy subjects. Study will be conducted in four periods; subjects will receive either placebo or GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period. Each period will be separated by washout period (at least 6 days from dosing). Total duration of study for each subject will be approximately 5 weeks from the first dosing to follow up visit.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bile acid-mediated signaling in cholestatic liver diseases.
   Zeng J, Fan J, Zhou H. · · 2023 · cited 39× · PMID 37120573 · DOI 10.1186/s13578-023-01035-1
2. Analysis of C4 Concentrations to Predict Impact of Patient-Reported Diarrhea Associated With the Ileal Bile Acid Transporter Inhibitor Linerixibat.
   Carreño F, Mehta R, de Souza AR, Collins J, et al · · 2025 · cited 1× · PMID 39945351 · DOI 10.1002/psp4.13300