WHO ICTRP trial
A phase I, open-label study to assess the pharmacokinetic profile, safety and…
NL-OMON40897 · Overview of Medical Research in the Netherlands (NL-OMON)
Key facts
| Trial ID | NL-OMON40897 |
|---|---|
| Public title | 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 |
| Scientific title | 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 |
| Primary sponsor | ObsEva SA |
| Registry | Overview of Medical Research in the Netherlands (NL-OMON) |
| Study type | Interventional |
| Countries | Netherlands ;United Kingdom |
| Conditions | NA (healthy volunteers);10010273;NA (healthy volunteers) |
| Interventions | Single oral intake of 600mg OBE001 (3x200mg) the day prior induced delivery. ;OBE001;pharmacokinetic;pregnancy |
| Registration date | Jun 19, 2014 |
| Target size | 6 |
| Secondary IDs | 2013 005048-27;NL47768.000.14 |
| Registry page | onderzoekmetmensen.nl |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: