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For strategic reasons
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Multiple Doses of Lu AG06474 or Placebo | Experimental | Participants will receive multiple oral doses of Lu AG06474 or placebo. |
|
| Part B: Single Doses of Lu AG06474 | Experimental | Participants will receive single oral doses of Lu AG06474. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06474 | Drug | Oral Solution |
|
| Measure | Description | 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-Ï„: 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Miami | Miami | Florida | 33126 | United States |
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| Placebo | Drug | Oral Solution |
|
| Lu AG06474 | Drug | Capsule |
|