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NCT01627587
A Two Cohort Study to Look at the Metabolites of GSK221149, the Metabolism of GSK221149 Administered With a High Fat Meal and With Ketoconazole
Phase 1 trial testing GSK221149 750 mg in Obstetric Labour, Premature in 46 participants. Completed in 9 February 2012.
9 February 2012
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 46 |
| Start date | 12 December 2011 |
| Primary completion | 9 February 2012 |
| Estimated completion | 9 February 2012 |
| Sites | 1 location across United States |
Drugs / interventions tested
- GSK221149 750 mg — full drug profile →
- Ketoconazole (ketoconazole) — full drug profile →
- GSK221149 100 mg — full drug profile →
- GSK221149 750 mg Fasted — full drug profile →
- GSK221149 750 mg + Food — full drug profile →
Conditions studied
- Obstetric Labour, Premature — all drugs for Obstetric Labour, Premature →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 45, female only, with Obstetric Labour, Premature. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a two part study. Part A of the study will evaluate the metabolites of GSK221149 following single and repeat oral dosing and will also assess the pharmacokinetics of GSK221149 when administered with a potent CYP3A4 inhibitor Ketoconazole. Part B of the study will look at the pharmacokinetics of GSK221149 following a high fat meal.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01627587
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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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 NCT01627587 (US National Library of Medicine, public domain)
- 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: 15 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/NCT01627587.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing