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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-503987-18-00 | Other Identifier | CTIS |
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The main goal of this trial is to learn about the effect of Lu AG06474 on a battery of Evoked Pain Tests when a single dose is given to healthy adult participants. The effects of Lu AG06474 will be compared with 2 approved pain-relieving medications (ibuprofen and pregabalin) and with a placebo (a treatment that looks like the trial treatment but does not have any medicine in it). Each participant will receive 1 dose of each of these treatments during the trial (Lu AG06474, ibuprofen, pregabalin, and placebo), with 1 week between treatments. All treatments will be taken orally (by mouth), either as a liquid or a capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lu AG06474 + Placebo | Experimental | Participants will receive a single dose of Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules). |
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| Part B: Ibuprofen + Placebo to Lu AG06474 | Experimental | Participants will receive a single dose of ibuprofen (3 ibuprofen capsules) and a single dose of placebo to Lu AG06474 (oral solution). |
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| Part C: Pregabalin + Placebo to Lu AG06474 | Experimental | Participants will receive a single dose of pregabalin (1 capsule + 2 placebo capsules) and a single dose of placebo to Lu AG06474 (oral solution). |
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| Part D: Placebo to Lu AG06474 + Placebo | Experimental | Participants will receive a single dose of placebo to Lu AG06474 (oral solution) and a single dose of placebo (3 placebo capsules). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG06474 | Drug | Oral solution |
| |
| Placebo to Lu AG06474 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Detection Thresholds (PDTs) for the UVB Heat Pain Test | The PDT is the degrees Celsius where the participant first detects pain. | Baseline to 6 hours post-dose |
| Change From Baseline in Pain Detection Thresholds (PDTs) for the Capsaicin Heat Pain Test | The PDT is the degrees Celsius where the participant first detects pain. | Baseline to 6 hours post-dose |
| Change From Baseline in Area of Secondary Mechanical Allodynia After the Capsaicin Challenge | The area of secondary mechanical allodynia will be reported for the capsaicin challenge, measured in squared millimeters (mm^2). | Baseline to 6 hours post-dose |
| Change From Baseline in Pain Tolerance Thresholds (PTTs) for the Cold Pressor Test | The PTT is the timepoint (in seconds) where the participant can no longer tolerate the pain. | Baseline to 6 hours post-dose |
| Change From Baseline in Pain Detection Thresholds (PDTs) for the Cold Pressor Test | The PDT is the timepoint (in seconds) where the participant first detects the pain. | Baseline to 6 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-8h: Area Under the Curve Concentration-time Curve from Zero to 8 hours Post-dose | 0 (predose) to 8 hours postdose on Day 1 to Day 22 | |
| Cmax: Maximum Observed Plasma Concentration | 0 (predose) to 8 hours postdose on Day 1 to Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Human Drug Research | Leiden | 2333 CL | Netherlands |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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| Drug |
Oral solution |
|
| Ibuprofen | Drug | Capsule |
|
| Pregabalin | Drug | Capsule |
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| Placebo | Drug | Capsule |
|
| tmax: Nominal Time Corresponding to the Occurrence of Cmax | 0 (predose) to 8 hours postdose on Day 1 to Day 22 |
| Difference to Placebo in Blood Levels of Endocannabinoids | 0 (predose) to 8 hours postdose on Day 1 to Day 22 |
| D005680 |
| gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |