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OpenTrials
Completed

NCT Number: NCT06277609

A Trial Investigating Lu AF28996 in Healthy Adult Participants

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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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Dallas CRU

Dallas, Texas, 75247, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lu AF28996

Drug

Capsule

acetylsalicylic acid

Drug

Tablet

mefenamic acid

Drug

Tablet

Amoxicillin/clavulanic acid

Drug

Tablet

Primary outcomes

  1. Maximum Observed Concentration (Cmax) of Lu AF28996

    Time frame: Predose to Day 13

  2. Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996

    Time frame: Predose to Day 13

Secondary outcomes

  1. Nominal Time Corresponding to the Occurrence of Cmax

    Time frame: Predose to Day 13

Sponsors and collaborators

Lead sponsor

H. Lundbeck A/S

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 26, 2024
Registry last updated
Jun 11, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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