A Trial Investigating Lu AF28996 in Healthy Adult Participants

NCT06277609 | Completed Phase 1 FDA Drug

• 1 other identifier: 20508A
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Nominal Time Corresponding to the Occurrence of Cmax

  Predose to Day 13

Study Arms (2)

Part A: Lu AF28996 with Enzyme Inhibitors

EXPERIMENTAL

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

Drug: Lu AF28996; Drug: Acetylsalicylic Acid; Drug: Mefenamic Acid

Part B: Lu AF28996 with Antibiotics

EXPERIMENTAL

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

Drug: Lu AF28996; Drug: Amoxicillin/clavulanic acid

Interventions

Lu AF28996 DRUG

Capsule

Part A: Lu AF28996 with Enzyme Inhibitors; Part B: Lu AF28996 with Antibiotics

Acetylsalicylic Acid DRUG

Tablet

Part A: Lu AF28996 with Enzyme Inhibitors

Mefenamic Acid DRUG

Tablet

Part A: Lu AF28996 with Enzyme Inhibitors

Amoxicillin/clavulanic acid DRUG

Tablet

Part B: Lu AF28996 with Antibiotics

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (1)

Covance Dallas CRU

Dallas, Texas, 75247, United States

Location

MeSH Terms

Interventions

Aspirin; Mefenamic Acid; Amoxicillin-Potassium Clavulanate Combination

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Fenamates; ortho-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Clavulanic Acid; Clavulanic Acids; beta-Lactams; Lactams; Amides; Amoxicillin; Ampicillin; Penicillin G; Penicillins; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: February 26, 2024
• Study Start: February 27, 2024
• Primary Completion: May 19, 2024
• Study Completion: May 19, 2024
• Last Updated: June 11, 2024

Record last verified: 2024-06

Locations

US (1)