NL-OMON40897
Withdrawn
Not Applicable
A phase I, open-label study to assess the pharmacokinetic profile, safety and tolerability of OBE001 after a single oral administration in pregnant women with medically indicated pregnancy termination - OBE001 Phase I PK study in pregnant women with indicated termination
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- NA (healthy volunteers)
- Sponsor
- ObsEva SA
- Enrollment
- 6
- Status
- Withdrawn
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.The Subject must provide written informed consent prior to initiation of any study related procedures, as shown by a signature on the volunteer consent form.
- •2\.The Subject must be an adult woman aged from 18 and above at screening.
- •3\.The Subject must be a healthy pregnant female volunteer.
- •4\.The Subject must have a medically indicated pregnancy termination for fetal indication (e.g. genetic abnormality and/or congenital malformation).
- •5\.The Subject must have a pregnancy with a gestational age (confirmed by US scan done prior Week 20\+0/7\) at the time of planned pregnancy termination being between 14\+0/7 (inclusive) week and upper limit for legal pregnancy termination in the center country.
- •6\.The Subject must have a singleton pregnancy.
- •7\.The Subject must be non\-smoker or must be a light smoker (less than 5 cigarettes per day). No smoking (or smoking substitute e.g. nicotine patch) is permitted from screening and throughout the study.
- •8\.The Subject must be able to communicate well with the investigator and research staff and to comply with the requirements of the study protocol.
Exclusion Criteria
- •1\.The Subject has a current pregnancy with a dead fetus.
- •2\.The subject has a current pregnancy with an expected high risk of fetal death in the coming days, including severe fetal cardiac malformation, fetal cystic hygroma or hydrops fetalis.
- •3\.The Subject had a BMI \>\= 35 kg/m2 prior to current pregnancy.
- •4\.The Subject has a current body weight \< 50kg.
- •5\.The Subject has any condition, including findings in the medical history or in the pre\-trial assessments, which in the opinion of the investigator constitutes a risk or a contraindication for the participation of the subject in the trial or that could interfere with the trial objectives, conduct or evaluation.
- •6\.The Subject has any clinically significant abnormality in the results of the screening safety laboratory tests, including AST, ALT, GGT, alkaline phosphatase or total bilirubin above twice upper limit of normal. In case of isolated GGT increase, a single re\-test is allowed.
- •7\.The Subject has any clinically significant abnormality in the results of the screening physical examination which in the opinion of the Investigator could interfere with the trial objectives, conduct and evaluation.
- •8\.The Subject has any clinically significant abnormality in the results of the screening gynaecological examination which in the opinion of the investigator could interfere with the trial objectives, conduct and evaluation.
- •9\.The Subject has any clinically significant abnormality on the 12\-lead ECG recording at screening.
- •10\.The Subject has any clinically significant abnormality on arterial blood pressure (BP) or heart rate (HR) at screening.
Outcomes
Primary Outcomes
Not specified
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