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This study aims to evaluate the impact of strong CYP3A4 induction on the pharmacokinetics (PK) of atumelnant, as well as the effect of atumelnant on CYP3A4, P-gp, and MATE1/2-K substrates in healthy participants.
This is a Phase 1, open-label, two-Cohort Study to assess the effect of a strong CYP3A4 inducer on the pharmacokinetics of atumelnant and the effect of atumelnant on the pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in healthy participants.
Approximately 20 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 1. Approximately 26 healthy male and female participants adult male and female (of non-childbearing potential) participants will be enrolled in Cohort 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | atumelnant, carbamazepine (CYP3A4 Inducer) |
|
| Cohort 2 | Experimental | atumelnant, midazolam (CYP3A4 substrate), digoxin (P-gp substrate), metformin (MATE1/2-K substrate) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atumelnant | Drug | Atumelnant, tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Pharmacokinetics (AUC 0-last) | Up to Day 34 | |
| Cohort 1: Pharmacokinetics (AUC 0-inf) | Up to Day 34 | |
| Cohort 1: Pharmacokinetics (Cmax) | Up to Day 34 | |
| Cohort 2: Pharmacokinetics (AUC 0-last) | Up to Day 21 | |
| Cohort 2: Pharmacokinetics (AUC 0-inf) | Up to Day 21 | |
| Cohort 2: Pharmacokinetics (Cmax) | Up to Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Number of participants with Treatment Emergent Adverse Events | Up to Day 34 | |
| Cohort 2: Number of participants with Treatment Emergent Adverse Events | Up to Day 21 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crinetics Study Site | Lincoln | Nebraska | 68502 | United States |
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| ID | Term |
|---|---|
| D002220 | Carbamazepine |
| D008874 | Midazolam |
| D004077 | Digoxin |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Carbamazepine | Drug | CYP3A4 inducer |
|
| Midazolam | Drug | CYP3A4 substrate |
|
| Digoxin | Drug | P-gp substrate |
|
| Metformin | Drug | MATE1/2-K substrate |
|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |