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Drug-drug Interaction Study of GSK1278863 With Pioglitazone, Rosuvastatin and Trimethoprim in Healthy Adult Volunteers

NCT02371603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-11-17

No results posted yet for this study

Summary

This study will be a two-part with an open-label, single oral dose, two-way crossover study design. Part A and Part B of the study are independent and may be conducted in parallel. The Part A of the study will assess the effect of an oral dose of GSK1278863 on the pharmacokinetics of a CYP2C8 (pioglitazone) and OATP1B1 (rosuvastatin) probe substrate in order to determine the potential for clinically-significant drug interactions with CYP2C8 and OATP1B1 substrates. The Part B of the study will assess the effect of a weak CYP2C8 inhibitor (trimethoprim) on the pharmacokinetics of GSK1278863 and its six predominant metabolites. Part A will be conducted in approximately 30 healthy subjects, having a randomized study design. There will be approximate 7-day washout period between each dosing period. Part B will be conducted in approximately 20 healthy subjects, having single sequence study design. Follow up will be conducted within 7 to 10 days after the last dose in both Part A and B. The total duration of a subject's involvement in the part A of the study will be approximately 8 weeks (Screening to Follow-up) and in part B will be approximately 7 weeks (Screening to Follow-up).

Conditions

  • Anaemia

Interventions

DRUG

GSK1278863 25 mg Tablet

A round, biconvex, white film coated tablet to be taken orally in the fasted state in the morning

DRUG

Pioglitazone 15 mg Tablet

White to off-white, round, convex, non scored tablet with "ACTOS" on one side, and "15" on the other, to be taken orally in the fasted state in the morning

DRUG

Rosuvastatin 10 mg Tablet

Pink, round, biconvex, coated tablets. Debossed "CRESTOR" and "10" on one side, to be taken orally in the fasted state in the morning

DRUG

Trimethoprim 100 mg Tablet

White, round, scored, convex tablet, debossed "93" above the score and debossed "2159" below the score on one side and plain on the other, to be taken orally as two tablets once in the morning and once in the evening

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-11
Primary Completion
2015-08-12
Completion
2015-08-12

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02371603 on ClinicalTrials.gov