A phase I, open label study to investigate the absorption, metabolism and excretion of 14C-ESN-364 in healthy menopausal female volunteers.

Completed

• Conditions: geslachtshormoon gerelateerde aandoeningen; sex-hormone-related disorders

• Registration Number: NL-OMON46563
• Lead Sponsor: Ogeda

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

healthy female menopausal subjects
40-75 years, inclusive,
BMI 18.0-30.0 kg/m2, inclusive
50.0-100.0 kg, inclusive

Exclusion Criteria

Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the pharmacokinetics (PK) of ESN-364 and total radioactivity, in<br /><br>particular, absorption, rates and routes of excretion and extent of metabolism<br /><br>of ESN-364, following administration of a single dose of 14C labeled ESN-364<br /><br><br /><br>To determine the mass balance of total radioactivity</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the PK of ES259564, the major metabolite, following administration<br /><br>of a single oral dose of 14C-labeled ESN-364<br /><br><br /><br>To evaluate the safety of single oral dose administration of ESN-364 in healthy<br /><br>volunteers<br /><br><br /><br>To identify the metabolic profile of ESN-364 in plasma, urine and feces after a<br /><br>single oral dose of 14C labeled ESN-364</p><br>