geslachtshormoon gerelateerde aandoeningen sex-hormone-related disorders
Conditions
Interventions
not applicable.
Sponsors
Ogeda
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the pharmacokinetics (PK) of ESN-364 and total radioactivity, in particular, absorption, rates and routes of excretion and extent of metabolism of ESN-364, following administration of a single dose of 14C labeled ESN-364 To determine the mass balance of total radioactivity | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the PK of ES259564, the major metabolite, following administration of a single oral dose of 14C-labeled ESN-364 To evaluate the safety of single oral dose administration of ESN-364 in healthy volunteers To identify the metabolic profile of ESN-364 in plasma, urine and feces after a single oral dose of 14C labeled ESN-364 | — |
Countries
Netherlands
Outcome results
None listed