NCT01867996 is a Phase 1 clinical trial of Retosiban in Obstetric Labour, Premature, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01867996?

NCT01867996 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01867996?

Interventions in NCT01867996: Retosiban, EFZ 600 mg.

What condition does NCT01867996 study?

NCT01867996 studies Obstetric Labour, Premature.

Is NCT01867996 still recruiting?

NCT01867996 is currently completed. Last updated 11 May 2017.

Last reviewed 2017-05-11 · How we verify

NCT01867996

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Retosiban (GSK221149) When Dosed With Efavirenz (EFZ)

Completed Phase 1 Last updated 11 May 2017

What this trial tests

Phase 1 trial testing Retosiban in Obstetric Labour, Premature in 18 participants. Completed in 26 September 2013.

Timeline

11 June 2013

Primary endpoint
26 September 2013

26 September 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	18
Start date	11 June 2013
Primary completion	26 September 2013
Estimated completion	26 September 2013
Sites	1 location across United States

Drugs / interventions tested

Retosiban — full drug profile →
EFZ 600 mg — 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, any sex, with Obstetric Labour, Premature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This will be a randomized single sequence open label study. This study is designed to determine if chronic dosing with efavirenz (EFZ) will have an effect on the pharmacokinetics (PK) of intravenously-administered retosiban in healthy volunteers. The study consists of screening (28 days), treatment (1 dosing session) and follow-up (7 to 14 days) period, and the total duration of study participation for each subject will be approximately 8 weeks. During the treatment period, subjects will be admitted to the clinical research unit the day before dosing (Day 1) and will remain until completion of the last assessment on Day 20. All subjects will receive on Day 1, a 6 milligrams (mg) bolus of retosiban for 5 minutes (min), followed by a 6 mg/hour (hr) infusion for 12 hrs. On Day 2, a washout day will occur. On Days 3-17, subjects will receive EFZ 600 mg once daily in the evening. On Day 18, subjects will receive a 6 mg bolus of retosiban for 5 mins, followed by a 6 mg/hr infusion for 12 hrs plus a 600 mg dose of EFZ.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Effect of Efavirenz on the Pharmacokinetics of SHR6390 in Healthy Volunteers.
Wang J, Hu C, Zhang L. · · 2024 · cited 3× · PMID 39050802 · DOI 10.2147/dddt.s468478

Verify or expand the search:

Other trials of Retosiban

Trials testing the same drug.

NCT02292784 — Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosib · Phase 3 · completed
NCT02292771 — A Randomized Study Comparing the Efficacy and Safety of Retosiban Versus Atosiban for Women in Spontaneous Preterm Labou · Phase 3 · terminated

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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01867996 (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: 11 May 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/NCT01867996.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing