Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02653872 | A Phase I Study to Assess PK of AZD7986 Alone & With Verapamil, Itraconazole or Diltiazem in Healthy Subjects | PHASE1 | COMPLETED | 15 | — | — | Jan 22, 2016 | Apr 13, 2016 | Feb 23, 2018 | 1 | United Kingdom |
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
To assess the effect of verapamil and itraconazole on the PK of AZD7986.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
To assess the effect of Verapamil and Itraconazole on the PK of AZD7986.
To assess the area under the plasma concentration-time curve from time over the dosing interval tau (24 hours) of Verapamil, itraconazole and OH-itraconazole (a metabolite of Itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.
To assess the time to reach maximum observed concentration of Verapamil, Itraconazole and OH-itraconazole (a metabolite of itraconazole) following co-administration of AZD7986 with Verapamil or Itraconazole.
| Arm | Type | Description |
|---|---|---|
| AZD7986 (alone) Treatment period 1 | EXPERIMENTAL | AZD7986 (15 mg/mL) 25 mg dosage administered alone |
| Verapamil (with AZD7986) Treatment period 2 | ACTIVE_COMPARATOR | Daily administration of verapamil (240 mg, extended release formulation) on Days 1 to 10 plus administration of single dose AZD7986 (25 mg) on Day 5 |
| Itraconazole (with AZD7986) Treatment Period 3 | ACTIVE_COMPARATOR | Itraconazole (200 mg, oral solution formulation 10 mg/mL) administered twice on Day 1 and then daily Days 2 to 11 plus single dose AZD7986 (25 mg, tbc) on Day 6 |
| Diltiazem (with AZD7986) Treatment period 3 | ACTIVE_COMPARATOR | Diltiazem (360 mg, extended release formulation) administered Days 1 to 13 plus single dose AZD7986 (25 mg) on Day 8 |
| Name | Type | Description |
|---|---|---|
| AZD7986 | DRUG | Oral solution, single dose, dilution from concentrate |
| Verapamil | DRUG | Extended release tablet for oral use |
| Itraconazole | DRUG | Oral solution |
| Diltiazem | DRUG | Extended release capsule |
Inclusion Criteria: 1. Provision of signed and dated, written informed consent prior to any study specific procedures. 2. Healthy male and/or female subjects aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venepuncture. 3. Females must have a negative pregnancy test ...