Safety and PK/PD of nolasiban in healthy female volunteers
Research type
Research Study
Full title
A phase 1, double-blind, randomized, placebo-controlled, parallel study to assess the safety and PK/PD effects of a single oral administration of nolasiban in healthy female volunteers.
IRAS ID
254492
Contact name
Peter Mc Dowell
Contact email
Sponsor organisation
ObsEva S.A
Eudract number
2018-003702-36
Duration of Study in the UK
0 years, 3 months, 11 days
Research summary
Assisted reproductive technology has advanced significantly in 40 years, however overall effectiveness of even the most advanced treatments such as in vitro fertilization (IVF) and embryo transfer (ET) remains relatively low, at about 30% live births per treatment cycle. \n\nNolasiban is being developed by ObsEva S.A. to increase ongoing pregnancy rate following fresh, single blastocyst transfer resulting from IVF.\n \nPart I is a single ascending dose trial and Part II will further clarify the mechanism of action of nolasiban.\n\nIn Part I, the safety, tolerability and PK of single ascending doses of nolasiban will be studied. Up to 20 volunteers will be included in up to three cohorts (one optional cohort). Cohort 1 has four volunteers; three 1800 mg nolasiban, one placebo. Cohort 2 has eight volunteers; six 2400 mg nolasiban, two placebo. An optional Cohort 3 may be conducted with eight volunteers (six active, two placebo). \n\nIn Part II the mode of action of nolasiban will be studied. 63 volunteers will be included in Part II in up to three cohorts (one optional cohort). Twenty-one volunteers are planned to be included in each cohort (2:1 nolasiban to placebo). The planned doses are 900 mg (Cohort 1) and 1800 mg (Cohort 2). Part II will require direct assessment of the endometrium by ultrasound scan and biopsy. \n\nTo date nolasiban has been given in eight trials (a total of 673 volunteers), five Phase I, two Phase II and one Phase III. Over 628 volunteers were exposed to a single dose of nolasiban, (30 mg to 1500 mg) with 450 volunteers receiving 900mg or more. Forty-five volunteers received multiple doses; with cumulative dose ranging: 630 mg-6300 mg (five received this maximum cumulative dose). \n\nNolasiban was safe and well tolerated at all tested dose levels.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
18/SC/0606
Date of REC Opinion
2 Jan 2019
REC opinion
Further Information Favourable Opinion