A Trial Investigating Lu AF28996 in Healthy Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-27

Study Completion Date

2024-05-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy Participants

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part A: Lu AF28996 with Enzyme Inhibitors

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

Group Type EXPERIMENTAL

Lu AF28996

Intervention Type DRUG

Capsule

Acetylsalicylic Acid

Intervention Type DRUG

Tablet

Mefenamic Acid

Intervention Type DRUG

Tablet

Part B: Lu AF28996 with Antibiotics

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

Group Type EXPERIMENTAL

Lu AF28996

Intervention Type DRUG

Capsule

Amoxicillin/clavulanic acid

Intervention Type DRUG

Tablet

Interventions

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Lu AF28996

Capsule

Intervention Type DRUG

Acetylsalicylic Acid

Tablet

Intervention Type DRUG

Mefenamic Acid

Tablet

Intervention Type DRUG

Amoxicillin/clavulanic acid

Tablet

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes