A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants
- Conditions
- Vasomotor Symptoms
- Interventions
- Drug: Treatment ADrug: Treatment BDrug: Treatment C
- Registration Number
- NCT07229404
- Lead Sponsor
- Bayer
- Brief Summary
The aim of this study is to examine the relative bioavailability of elinzanetant when administered in new oral formulations (treatment B and C) after both single and multiple oral doses, compared to its administration in soft gel capsule form (treatment A).
Study details include:
An ambulatory screening visit within 4 weeks prior to first treatment. Participants will be admitted to the ward on Day -1 of each period. On Day 1, either treatment B or treatment C will be administered fasted in the evening, followed by blood sampling for a 24-hour pharmacokinetic (PK) profile.
On Day 2, the multiple dosing starts 3 hours after a standardized dinner in the evening.
After the last dosing on Day 7, a complete PK profile for 24 hours will be collected.
If there are no medical objections, participants will be discharged from the study ward on Day 9 in the morning for a washout-out period of at least 10 days (240 hours after last dosing, after period 1 and 2) or, in period 3, after the follow-up examination.
The total duration of the study will be approximately 10 to 12 weeks for each participant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 16
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Sequence 1 Treatment A Treatments are administered in sequence of A-B-C Sequence 1 Treatment B Treatments are administered in sequence of A-B-C Sequence 1 Treatment C Treatments are administered in sequence of A-B-C Sequence 2 Treatment A Treatments are administered in sequence of A-C-B Sequence 2 Treatment B Treatments are administered in sequence of A-C-B Sequence 2 Treatment C Treatments are administered in sequence of A-C-B Sequence 3 Treatment A Treatments are administered in sequence of C-A-B Sequence 3 Treatment B Treatments are administered in sequence of C-A-B Sequence 3 Treatment C Treatments are administered in sequence of C-A-B Sequence 4 Treatment A Treatments are administered in sequence of C-B-A Sequence 4 Treatment B Treatments are administered in sequence of C-B-A Sequence 4 Treatment C Treatments are administered in sequence of C-B-A Sequence 5 Treatment A Treatments are administered in sequence of B-C-A Sequence 5 Treatment B Treatments are administered in sequence of B-C-A Sequence 5 Treatment C Treatments are administered in sequence of B-C-A Sequence 6 Treatment B Treatments are administered in sequence of B-A-C Sequence 6 Treatment C Treatments are administered in sequence of B-A-C Sequence 6 Treatment A Treatments are administered in sequence of B-A-C
- Primary Outcome Measures
Name Time Method AUC(0-24)md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C) From Day 0 to Day 8 Cmax,md and Cmin,,md after multiple oral dosing 3 h after light dinner in the evening (treatments A, B, C) From Day 0 to Day 8
- Secondary Outcome Measures
Name Time Method AUC(0-24) after single dose in the evening under fasted condition (treatments A, B, C). From Day 0 to Day 8 Cmax after single dose in the evening under fasted condition (treatments A, B, C). From Day 0 to Day 8 Number and severity of treatment-emergent adverse events (TEAEs) after first study intervention until follow up From first dosing up to Day 9
Trial Locations
- Locations (1)
Altasciences
🇨🇦Mount Royal, Quebec, Canada
Altasciences🇨🇦Mount Royal, Quebec, Canada