NCT02720224

Study Conducted to Further Understand the Elimination Pathways, Metabolite Profile and PK Profile of 14C-estetrol

An Open-Label, Single Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profiles and Metabolite Identification of [14C]-Estetrol in Healthy Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Estetra · Industry
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to further understand the elimination pathways, metabolite profile and pharmacokinetic (PK) profile of carbon 14 labelled estetrol (\[14C\] estetrol).

Detailed description

This will be an open-label, non-randomised, single dose study in healthy female volunteers of non-child bearing potential. Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. The study will be executed in a single group, 6 subjects will be enrolled and dosed with a single oral dose of carbon 14 labelled estetrol. Subjects will be admitted to the clinical unit on the morning prior to study drug administration (Day -1). Dosing will take place on the morning of Day 1 after an overnight fast (approximately 10 h). Subjects will be resident in the clinic up to 240 h after dosing during which plasma, blood, urine and faeces samples will be collected. It is planned that subjects will be released as a group when all subjects have achieved a mass balance cumulative recovery of \>90% or if a mean of \<1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. In this case, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects on Day 11, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.

Conditions

• Contraception
• Menopause

Interventions

Type	Name	Description
DRUG	Estetrol	15 mg \[14C\]-estetrol containing approximately 2.8 MBq (76 μCi) 14C

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-03-01
• Completion: 2016-04-01
• First posted: 2016-03-25
• Last updated: 2019-02-15
• Results posted: 2018-12-10

Locations

1 site across 1 country: United Kingdom