A Trial Investigating Lu AF28996 in Healthy Adult Participants

Lundbeck

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: Mefenamic Acid; Drug: Acetylsalicylic Acid; Drug: Lu AF28996; Drug: Amoxicillin/clavulanic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06277609

20508A

Details and patient eligibility

About

The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.

Full description

The study has 2 parts: Part A and Part B.

Part A will consist of 2 cohorts (Cohorts A1 to A2), with 8 participants per cohort and will receive single doses of Lu AF28996 alone and in combination with enzyme inhibitors.

Part B will consist of one cohort (Cohort B1), with 8 participants who will all receive single doses of Lu AF28996 alone and in combination with amoxicillin/clavulanic acid.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The participant has a body mass index (BMI) ≥18.5 and ≤30 kilograms per meter squared (kg/m^2) at the Screening Visit and at the Safety Baseline Visit.
• The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Safety Baseline Visit.
• The participant has a resting supine systolic blood pressure ≥90 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥50 and ≤90 mmHg at the Screening Visit and at the Safety Baseline Visit.
• The participant has a normal circadian rhythm, defined as a person who usually wakes between 6:00 and 9:00 a.m. and goes to sleep between 9:00 p.m. and midnight.

Exclusion criteria

• The participant is a member of the site staff or of their immediate families or is a subordinate (or immediate family member of a subordinate) to any of the site staff.
• Part B only, the participant is a woman of childbearing potential AND is using oral hormonal contraceptives.
• The participant has previously been enrolled in this trial.
• The participant has previously been dosed with Lu AF28996.

Note: Other inclusion and exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

Part A: Lu AF28996 with Enzyme Inhibitors

Experimental group

Description:

Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.

Treatment:

Drug: Lu AF28996

Drug: Acetylsalicylic Acid

Drug: Mefenamic Acid

Part B: Lu AF28996 with Antibiotics

Experimental group

Description:

Participants will receive single doses of Lu AF28996 and amoxicillin/clavulanic acid.

Treatment:

Drug: Amoxicillin/clavulanic acid

Drug: Lu AF28996