Altasciences
Mount Royal, Quebec, H3P 3P1, Canada
NCT Number: NCT07229404
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.
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Notify Me18 year–65 year
Female
Interventional
Phase 1
Mount Royal, Quebec, H3P 3P1, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Elinzanetant (BAY 3427080), dosage 1
Elinzanetant (BAY 3427080), dosage 2
Elinzanetant (BAY 3427080), dosage 3
Time frame: From Day 0 to Day 8
Time frame: From Day 0 to Day 8
Time frame: From Day 0 to Day 8
Time frame: From Day 0 to Day 8
Time frame: From first dosing up to Day 9
Bayer
Industry
A Combined Single- and Multiple-dose, Open-label, Randomized, 6 x 3 Crossover Study to Investigate the Relative Bioavailability, Safety and Tolerability of Elinzanetant (BAY 3427080) in Healthy Female Participants
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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