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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003615-26 | EudraCT Number |
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A study on whether ACT-1014-6470 has an effect on how the body takes up, distributes and gets rid of omeprazole and midazolam in healthy male subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT-1014-6470, Midazolam and Omeprazole | Experimental | Treatment Period A (Day 1 to Day 2) The plan is that all participants will receive treatment A and then treatment B.
Treatment Period B (Day 8 to Day 11)
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Treatment period A | Drug | Midazolam solution for oral administration. Omeprazole hard capsule for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of ACT-1014-6470, midazolam and omeprazole. | The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| Time to reach Cmax (tmax) of ACT-1014-6470, midazolam and omeprazole. | The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| The area under the plasma concentration-time curve (AUC) from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of ACT-1014-6470, midazolam and omeprazole. | The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| Area under the plasma concentration-time curve [AUC(0-12)] of omeprazole. | The plasma pharmacokinetic parameters of omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profile. | Total duration: up to 9 days |
| Area under the plasma concentration-time curve [AUC(0-24)] of midazolam and omeprazole. | The plasma pharmacokinetic parameters of midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| Area under the plasma concentration-time curve [AUC(0-inf)] of ACT-1014-6470, midazolam and omeprazole. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole. | The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| Time to reach Cmax (tmax) of 1-hydroxymidazolam and 5-hydroxyomeprazole. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Idorsia Pharmaceuticals Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CEPHA s.r.o. | Pilsen | 32300 | Czechia |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D009853 | Omeprazole |
| C000726455 | ACT-1014-6470 |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Two-period, fixed-sequence study
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| Treatment period B | Drug | ACT-1014-6470 soft capsule for oral administration. Midazolam solution for oral administration. Omeprazole hard capsule for oral administration. |
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The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. |
| Total duration: up to 11 days |
| Apparent total body clearance (CL/F) of ACT-1014-6470, midazolam and omeprazole. | The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| The terminal half-life (t½) of ACT-1014-6470, midazolam and omeprazole. | The plasma pharmacokinetic parameters of ACT-1014-6470, midazolam and omeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. |
| Total duration: up to 11 days |
| The area under the plasma concentration-time curve (AUC) from zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of 1-hydroxymidazolam and 5-hydroxyomeprazole. | The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| Area under the plasma concentration-time curve [AUC(0-12)] of 5-hydroxyomeprazole. | The plasma pharmacokinetic parameters of 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| Area under the plasma concentration-time curve [AUC(0-24)] of 1-hydroxymidazolam and 5-hydroxyomeprazole. | The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| Area under the plasma concentration-time curve [AUC(0-inf)] of 1-hydroxymidazolam and 5-hydroxyomeprazole. | The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| The terminal half-life (t½) of 1-hydroxymidazolam and 5-hydroxyomeprazole. | The plasma pharmacokinetic parameters of 1-hydroxymidazolam and 5-hydroxyomeprazole will be derived by non-compartmental analysis of the plasma concentration-time profiles. | Total duration: up to 11 days |
| The metabolic ratio (MR) of 1-hydroxymidazolam to midazolam . | Total duration: up to 11 days |
| The metabolic ratio (MR) of 5-hydroxyomeprazole to omeprazole. | Total duration: up to 11 days |
| Number of participants with treatment-emergent adverse events as a measure of safety and tolerability. | An adverse event is an unfavorable and unintended sign (including an abnormal laboratory finding, an abnormal electrocardiogram). A treatment-emergent adverse event is any adverse event temporally associated with the use of a study treatment, whether or not considered related to the study treatment. | Total duration: up to 11 days |
| D006571 | Heterocyclic Compounds |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D001562 | Benzimidazoles |