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The purpose of this study is to investigate repeated doses of Lu AF28996 in healthy participants and co-administered with two other compounds, and in a separate cohort following co-administration with antibiotics, to see how well the doses are tolerated and what the body does to the drug after administering it.
The study has 2 parts: Part A and Part B.
Part A will consist of 2 cohorts (Cohorts A1 to A2), with 8 participants per cohort and will receive single doses of Lu AF28996 alone and in combination with enzyme inhibitors.
Part B will consist of one cohort (Cohort B1), with 8 participants who will all receive single doses of Lu AF28996 alone and in combination with amoxicillin/clavulanic acid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: Lu AF28996 with Enzyme Inhibitors | Experimental | Participants will receive repeated single doses of Lu AF28996 and enzyme inhibitors. |
|
| Part B: Lu AF28996 with Antibiotics | Experimental | Participants will receive single doses of Lu AF28996 and amoxicillin/clavulanic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AF28996 | Drug | Capsule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Concentration (Cmax) of Lu AF28996 | Predose to Day 13 | |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of Lu AF28996 | Predose to Day 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Nominal Time Corresponding to the Occurrence of Cmax | Predose to Day 13 |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Dallas CRU | Dallas | Texas | 75247 | United States |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D008528 | Mefenamic Acid |
| D019980 | Amoxicillin-Potassium Clavulanate Combination |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Acetylsalicylic Acid | Drug | Tablet |
|
| Mefenamic Acid | Drug | Tablet |
|
| Amoxicillin/clavulanic acid | Drug | Tablet |
|
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D054361 | Fenamates |
| D062367 | ortho-Aminobenzoates |
| D062365 | Aminobenzoates |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D019818 | Clavulanic Acid |
| D002969 | Clavulanic Acids |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D000658 | Amoxicillin |
| D000667 | Ampicillin |
| D010400 | Penicillin G |
| D010406 | Penicillins |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |