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The main objective of this study is to assess the effect of DC-806 on the pharmacokinetics (PK) of cytochrome 3A4 (CYP3A4) substrate, midazolam and its active metabolite, 1-hydroxymidazolam, cytochrome 2C8 (CYP2C8) substrate repaglinide, P-glycoprotein (P-gp) transporter substrate digoxin, and breast cancer resistant protein (BCRP)/ organic anion transporter protein-1B1 (OATP1B1) transporter substrate rosuvastatin in healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: DC-806 + Midazolam (CYP3A4 substrate) + Repaglinide (CYP2C8 substrate) | Experimental | Participants will receive a single oral dose of the 2-probe substrate cocktail (midazolam and repaglinide) on Day 1. From Day 4 through Day 8, participants will receive twice-daily (BID) oral doses of DC-806 and a single oral dose of the 2-probe substrate cocktail on Day 7. DC-806 BID dosing will continue until the end of Day 8. |
|
| Cohort 2: DC-806 + Digoxin (P-gp substrate) + Rosuvastatin (BCRP/OATP1B1 substrate) | Experimental | Participants will receive a single oral dose of the 2-probe substrate cocktail (digoxin and rosuvastatin) on Day 1. From Day 5 through Day 9, participants will receive twice daily oral doses of DC-806 and a single oral dose of the 2-probe substrate cocktail on Day 8. DC-806 BID dosing will continue until the end of Day 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-806 | Drug | Oral tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 1: Maximum Observed Plasma Concentration (Cmax) of Midazolam | Day 1 and Day 7 | |
| Cohort 1: Cmax of 1-hydroxymidazolam | Day 1 and Day 7 | |
| Cohort 1: Cmax of Repaglinide | Day 1 and Day 7 | |
| Cohort 2: Cmax of Digoxin | Day 1 and Day 8 | |
| Cohort 2: Cmax of Rosuvastatin | Day 1 and Day 8 | |
| Cohort 1: Area Under the Plasma Concentration-time Curve (AUC) up to Time t, Where t is the Last Point with Concentrations Above the Lower Limit of Quantification (AUC0-t) of Midazolam | Days 1-3 and Days 7-9 | |
| Cohort 1: AUC0-t of 1-hydroxymidazolam | Days 1-3 and Days 7-9 | |
| Cohort 1: AUC0-t of Repaglinide | Days 1-3 and Days 7-9 | |
| Cohort 2: AUC0-t of Digoxin | Days 1-5 and Days 8-12 | |
| Cohort 2: AUC0-t of Rosuvastatin | Days 1-5 and Days 8-12 | |
| Cohort 1: AUC from Time 0 to Infinity (AUC0-inf) of Midazolam |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1 and 2: Number of Participant who Experience an Adverse Event | Up to a maximum 22 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Phase 1 Clinic | Salt Lake City | Utah | 84124 | United States |
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| Midazolam | Drug | Oral syrup |
|
| Repaglinide | Drug | Oral tablets |
|
| Digoxin | Drug | Oral tablets |
|
| Rosuvastatin | Drug | Oral tablets |
|
| Days 1-3 and Days 7-9 |
| Cohort 1: AUC0-inf of 1-hydroxymidazolam | Days 1-3 and Days 7-9 |
| Cohort 1: AUC0-inf of Repaglinide | Days 1-3 and Days 7-9 |
| Cohort 2: AUC0-inf of Digoxin | Days 1-5 and Days 8-12 |
| Cohort 2: AUC0-inf of Rosuvastatin | Days 1-5 and Days 8-12 |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| C072379 | repaglinide |
| D004077 | Digoxin |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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