A Study to Investigate Relative Bioavailability, Safety and Tolerability of Single- and Multiple-doses of Elinzanetant in Healthy Female Participants

Bayer

Status and phase: Completed; Phase 1

Conditions: Vasomotor Symptoms

Treatments: Drug: Treatment A; Drug: Treatment B; Drug: Treatment C

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229404

22790

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Female participant between 18 to 65 years of age (inclusive), at the time of signing the informed consent form (ICF).
• Participant is overtly healthy as determined by the investigator (including assessment of medical history, physical examination, blood pressure (BP), pulse rate, 12-lead electrocardiogram (ECG), body temperature, and clinical laboratory).
• Body weight of at least 50 kg and body mass index (BMI) above or equal to 18.0 and below or equal to 32.0 kg/m² at screening.
• Signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

• Diseases for which it can be assumed that the absorption, distribution, metabolism, elimination, and effects of the study intervention(s) will not be normal.
• Known or suspected allergy or hypersensitivity to any study intervention (active substances or excipients of the preparations) to be used in the study - including e.g. non-investigational medicinal products, challenge agents, or rescue medication.
• Febrile illness within 2 weeks before the start of the first study intervention.
• History of clinically relevant seizures.
• Alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), Bilirubin, or gamma-glutamyl transferase (GGT) > 1.2 x upper limit of normal (ULN).
• Previous (within 30 days before first administration of study intervention) or concomitant participation in another clinical study with study intervention(s).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

18 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Treatments are administered in sequence of A-B-C

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Sequence 2

Experimental group

Description:

Treatments are administered in sequence of A-C-B

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Sequence 3

Experimental group

Description:

Treatments are administered in sequence of C-A-B

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Sequence 4

Experimental group

Description:

Treatments are administered in sequence of C-B-A

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Sequence 5

Experimental group

Description:

Treatments are administered in sequence of B-C-A

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A

Sequence 6

Experimental group

Description:

Treatments are administered in sequence of B-A-C

Treatment:

Drug: Treatment C

Drug: Treatment B

Drug: Treatment A