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NCT01376232: DDI
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered With a High Fat Meal or an Inhibitor of CYP2C8 (Gemfibrozil)
Phase 1 trial testing GSK1278863 in Anaemia in 23 participants. Completed in 20 December 2010.
20 December 2010
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 23 |
| Start date | 8 November 2010 |
| Primary completion | 20 December 2010 |
| Estimated completion | 20 December 2010 |
| Sites | 1 location across India |
Drugs / interventions tested
- GSK1278863 — full drug profile →
- GSK1278863 + food — full drug profile →
- Gemfibrozil (Gemfibrozil) — full drug profile →
Conditions studied
- Anaemia — all drugs for Anaemia →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 55, any sex, with Anaemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study to Assess the Pharmacokinetics of GSK1278863A Coadministered with a High Fat Meal or an Inhibitor of CYP2C8 (gemfibrozil),\]
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Daprodustat: First Approval.
Dhillon S. · · 2020 · cited 47× · PMID 32880805 · DOI 10.1007/s40265-020-01384-y -
Effect of food and gemfibrozil on the pharmacokinetics of the novel prolyl hydroxylase inhibitor GSK1278863.
Johnson BM, Stier BA, Caltabiano S. · · 2014 · cited 38× · PMID 27128455 · DOI 10.1002/cpdd.83
Verify or expand the search:
- PubMed search for NCT01376232
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of GSK1278863
Trials testing the same drug.
- NCT02829320 — Efficacy and Safety Study of GSK1278863 in Japanese Hemodialysis Subjects With Anemia Associated With Chronic Kidney Dis · Phase 3 · completed
- NCT02689206 — Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Three-times Weekly Dosing of GSK1278863 in Hemodialysis-d · Phase 2 · completed
- NCT02231190 — GSK1278863 Effects on Eccentric Exercise-Induced Muscle Damage · Phase 1 · completed
- NCT02243306 — Study to Assess the Pharmacokinetics of GSK1278863 in Subjects With End Stage Renal Disease Undergoing Peritoneal Dialys · Phase 1 · completed
- NCT02075463 — Study to Evaluate the Safety and Efficacy of GSK1278863 in Recombinant Human Erythropoietin (rhEPO) Hyporesponsive Hemod · Phase 2 · terminated
Other recruiting trials for Anaemia
Currently open trials in the same condition.
- NCT07008261 — Robot-assisted Cystectomies With Regard to Blood Loss, Pain and Transfusions. · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01376232 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 9 June 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01376232.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing