A Trial Investigating Lu AF28996 in Healthy Adult Participants

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: Lu AF28996; Drug: Amoxicillin/clavulanic acid; Drug: Acetylsalicylic Acid; Drug: Mefenamic Acid

• Registration Number: NCT06277609
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-19
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-26
• Study Start: 2024-02-27
• Primary Completion: 2024-05-19
• Study Completion: 2024-05-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part B: Lu AF28996 with Antibiotics	Amoxicillin/clavulanic acid	Participants will receive single doses of Lu AF28996 and amoxicillin/clavulanic acid.
Part A: Lu AF28996 with Enzyme Inhibitors	Lu AF28996	Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.
Part B: Lu AF28996 with Antibiotics	Lu AF28996	Participants will receive single doses of Lu AF28996 and amoxicillin/clavulanic acid.
Part A: Lu AF28996 with Enzyme Inhibitors	Acetylsalicylic Acid	Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.
Part A: Lu AF28996 with Enzyme Inhibitors	Mefenamic Acid	Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors.

Primary Outcome Measures

Name	Time	Method
Maximum Observed Concentration (Cmax) of Lu AF28996	Predose to Day 13
Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996	Predose to Day 13

Secondary Outcome Measures

Name	Time	Method
Nominal Time Corresponding to the Occurrence of Cmax	Predose to Day 13

Trial Locations

Locations (1)

Covance Dallas CRU; 🇺🇸 Dallas, Texas, United States