Clinical trial NCT05943327: A Study Investigating Lu AG06474 in Healthy Young Participants
Official title: Interventional, Randomized, Double-blind, Sequential Cohort, Placebo-controlled, Multiple-dose Trial Investigating the Safety, Tolerability, and Pharmacokinetic and Pharmacodynamic Properties of Lu AG06474 in Healthy Young Men and Women, With an Open-label, Cross-over, Single-dose Part Investigating the Relative Bioavailability of a Capsule Formulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2023-07-13
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety of multiple oral doses of Lu AG06474, how well the doses are tolerated, and what the body does to the drug after administering it to healthy young participants. This study also aims to compare how the body absorbs and uses Lu AG06474 when it is given in capsule form versus when it is given as an oral solution.

Detailed description: The study has 2 parts: Part A and Part B.

Part A consists of up to 7 sequential cohorts (Cohorts A1 to A7), with 8 participants per cohort randomized to receive multiple doses of either Lu AG06474 or placebo: 6 will receive Lu AG06474 oral solution and 2 will receive placebo.

Part B consists of 1 cohort (Cohort B1), with 12 participants: all participants will receive 2 single doses of Lu AG06474 (one as an oral solution and one in capsule form), taken 3 days apart.

Eligibility criteria: 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 Baseline Visit.
* The participant has a resting supine pulse ≥50 and ≤100 beats per minute (bpm) at the Screening Visit and at the Baseline Visit. For physically/athletically well-trained participants, the lower limit is ≥45 bpm.
* The participant has a resting supine systolic blood pressure ≥91 and ≤140 millimeters of mercury (mmHg) and a resting supine diastolic blood pressure ≥51 and ≤85 mmHg at the Screening Visit and at the Baseline Visit.

Exclusion Criteria:

* The participant has previously been dosed with Lu AG06474.
* The participant has participated in a clinical trial \<30 days prior to the Screening Visit.
* The participant has taken any investigational medicinal product ≥30 days or \<5 half-lives of that product, whichever is longer, prior to the first dose of IMP.

Primary outcomes:
measure: Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs)
timeFrame: Up to Day 10
measure: Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5
timeFrame: Day 5
measure: Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval
timeFrame: Predose to Day 7
measure: Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474
timeFrame: Predose to Day 6
measure: Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax
timeFrame: Predose to Day 6
measure: Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474
timeFrame: Predose to Day 6
measure: Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity
timeFrame: Predose to Day 6
measure: Part A: Accumulation Index
timeFrame: Predose to Day 7
measure: Part B: Frel: Relative Bioavailability
timeFrame: Predose to Day 6
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences Miami
state: Florida
Study officials:
References: