A Trial Investigating Lu AF28996 in Healthy Adult Participants

Healthy Participants Clinical Trial

Official title:

Interventional, Open-label, Repeated Single-dose Trial Investigating the Effects of Enzyme Inhibition on the Pharmacokinetic Profile of Lu AF28996 and Its Metabolites in Healthy Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06277609
• Other study ID #: 20508A
• Status: Completed
• Phase: Phase 1
• Start date: February 27, 2024
• Est. completion date: May 19, 2024

Study information

• Verified date: June 2024
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 19, 2024
• Est. primary completion date: May 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• Lu AF28996
Capsule
• Acetylsalicylic Acid
Tablet
• Mefenamic Acid
Tablet
• Amoxicillin/clavulanic acid
Tablet

Locations

Country	Name	City	State
United States	Covance Dallas CRU	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Concentration (Cmax) of Lu AF28996		Predose to Day 13
Primary	Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996		Predose to Day 13
Secondary	Nominal Time Corresponding to the Occurrence of Cmax		Predose to Day 13