Healthy Participants
Conditions
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.
Interventions
DRUGLu AG06474
Oral Solution
DRUGPlacebo
Oral Solution
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parts A and B: Number of Participants with Treatment Emergent Adverse Events (AEs) | Up to Day 10 |
| Part A: Electrocardiogram (ECG) Parameter (delta QTcF) on Day 5 | Day 5 |
| Part A: AUC0-τ: Area Under the Lu AG06474 Plasma Concentration Curve During Dosing Interval | Predose to Day 7 |
| Parts A and B: Cmax: Maximum Observed Plasma Concentration of Lu AG06474 | Predose to Day 6 |
| Parts A and B: Tmax: Nominal Time Corresponding to the Occurrence of Cmax | Predose to Day 6 |
| Parts A and B: t½: Apparent Elimination Half-life of Lu AG06474 | Predose to Day 6 |
| Part B: AUC0-infinity: Area Under the Lu AG06474 Plasma Concentration Curve From Zero to Infinity | Predose to Day 6 |
| Part A: Accumulation Index | Predose to Day 7 |
| Part B: Frel: Relative Bioavailability | Predose to Day 6 |
Countries
United States
Outcome results
None listed