NCT02377414

Study to Investigate the Pharmacokinetics (PK), Safety and Tolerability of Retosiban in Healthy Japanese Women

Completed Phase 1 Last updated 9 May 2017

What this trial tests

Phase 1 trial testing Retosiban solution for Infusion in Obstetric Labour, Premature in 32 participants. Completed in 17 April 2015.

Timeline

2 March 2015

Primary endpoint
17 April 2015

17 April 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	32
Start date	2 March 2015
Primary completion	17 April 2015
Estimated completion	17 April 2015
Sites	1 location across United States

Drugs / interventions tested

• Retosiban solution for Infusion — full drug profile →
• Placebo

Conditions studied

• Obstetric Labour, Premature — all drugs for Obstetric Labour, Premature →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 20 to 45, female only, with Obstetric Labour, Premature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study in healthy, adult Japanese women will characterize the PK, safety and tolerability of retosiban at the therapeutic doses planned to be evaluated in Phase 3. The PK data will be compared to a sub-set of Caucasian women given the same dose of retosiban. This study has two cohorts, cohort 1 will be a double-blind sponsor-open (subjects and investigator blinded and sponsor unblinded), randomized, continuous 48 hours (h) infusion study in healthy, adult Japanese women of child-bearing potential. Cohort 2 is an open label and continuous retosiban 48 h infusion study in Caucasian, adult, healthy women of child bearing potential. So, the PK can be compared with those of Japanese women. Approximately 32 subjects will be enrolled. In cohort 1, approximately 24 subjects will be enrolled and randomized to retosiban and placebo (2:1 ratio) to have 18 women with 12 active, 6 placebo completed subjects. In Cohort 2, 8 subjects will be enrolled to have 6 competed subjects. The total duration of a subject's involvement in this part is anticipated to be up to 6 weeks (including the 28 day screening period).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.