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The main goal of this trial is to learn how a new tablet formulation of Lu AG06466 behaves in the body. Researchers will compare the new tablet formulation to the capsule formulation that is currently being tested in other clinical trials. They will measure the levels of the drug in the bloodstream for up to 3 days after participants take either the tablet or the capsule formulation. They will also look at whether the tablet formulation behaves differently when it is taken with and without food.
This study will consist of 6 sequences with 4 periods (3 days/period) in each sequence. The first 3 periods will be randomized. Each Lu AG06466 dose administration will be separated by a washout period of at least 72 hours.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG06466 Capsule, Fasted State | Experimental | Participants will receive 1 capsule of Lu AG06466 in a fasted state. |
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| Lu AG06466 Tablet, Fasted State | Experimental | Participants will receive 1 tablet of Lu AG06466 in a fasted state. |
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| Lu AG06466 Tablet, Fed State | Experimental | Participants will receive 1 tablet of Lu AG06466 in a fed state (high-fat meal). |
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| Lu AG06466 Tablet + Antacid, Fasted State | Experimental | Participants will receive 1 tablet of Lu AG06466 dosed in combination with antacid in a fasted state. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06466 Capsule | Drug | Hard capsule |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity AUC(0-inf) of Lu AG06466 | AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life). | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
| AUC(0-inf) of Metabolite Lu AG06988 | AUC(0-inf) is defined as AUC0-tlast + Clast * t1/2 / ln2 (where Clast is the last quantifiable concentration and t1/2 is the apparent elimination half-life). | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
| Area Under Plasma Concentration-Time Curve from Zero to Last Quantifiable Concentration (AUC0-tlast) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | |
| AUC0-tlast of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | |
| Maximum Observed Plasma Concentration (Cmax) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | |
| Cmax of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | |
| Time to Reach Cmax (Tmax) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 | |
| Tmax of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
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Inclusion Criteria:
Exclusion Criteria:
Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LabCorp Clinical Research Unit Ltd | Leeds | LS2 9LH | United Kingdom |
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| ID | Term |
|---|---|
| D000863 | Antacids |
| C013591 | aluminum hydroxide, magnesium hydroxide, drug combination |
| ID | Term |
|---|---|
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D005765 | Gastrointestinal Agents |
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The first 3 periods will be randomized.
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| Lu AG06466 Tablet |
| Drug |
Film-coated tablet |
|
| Antacid | Drug | Oral suspension |
|
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| Apparent Oral Clearance (CL/F) of Lu AG06466 | CL/F is defined as dose / AUC0-inf. | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
| Apparent Volume of Distribution (Vz/F) of Lu AG06466 | Vz/F is defined as CL/F * t1/2 / ln2. | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
| Apparent Elimination Half-life (t1/2) of Lu AG06466 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
| t1/2 of Metabolite Lu AG06988 | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
| Metabolic Ratio (MR) | MR is defined as AUC0-inf, Lu AG06988 / AUC0-inf, Lu AG06466. | 0 (predose) up to 72 hours postdose on Day 1 to Day 12 |
| D045506 | Therapeutic Uses |