NCT02371603

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

Completed Phase 1 Last updated 17 November 2017

What this trial tests

Phase 1 trial testing GSK1278863 25 mg Tablet in Anaemia in 70 participants. Completed in 12 August 2015.

Timeline

11 February 2015

Primary endpoint
12 August 2015

12 August 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	11 February 2015
Primary completion	12 August 2015
Estimated completion	12 August 2015
Sites	1 location across United States

Drugs / interventions tested

• GSK1278863 25 mg Tablet — full drug profile →
• Pioglitazone 15 mg Tablet
• Rosuvastatin 10 mg Tablet — full drug profile →
• Trimethoprim 100 mg Tablet — full drug profile →

Conditions studied

• Anaemia — all drugs for Anaemia →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 65, any sex, with Anaemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

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

1. Daprodustat: First Approval.
   Dhillon S. · · 2020 · cited 47× · PMID 32880805 · DOI 10.1007/s40265-020-01384-y
2. The drug interaction potential of daprodustat when coadministered with pioglitazone, rosuvastatin, or trimethoprim in healthy subjects.
   Caltabiano S, Mahar KM, Lister K, Tenero D, et al · · 2018 · cited 15× · PMID 29545948 · DOI 10.1002/prp2.327
3. Immunocyte lipid metabolic reprogramming: a novel pathway for targeted intervention in autoimmune diseases.
   Cui Y, Feng Z, Zhao Q, Dai H, et al · · 2025 · PMID 41280910 · DOI 10.3389/fimmu.2025.1713148