Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD7986 · 1 trial · 1 indication
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 ...
AZD7986 is an investigational small molecule being studied in healthy volunteers for safety, pharmacokinetics, pharmacodynamics, and food effect. It is in Phase 1 clinical development and is not approved for any indication.
AZD7986 is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company is conducting Phase 1 clinical trials to evaluate the drug in healthy subjects.
AZD7986 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are being conducted to assess its safety, pharmacokinetics, and pharmacodynamics.
AZD7986 has been studied in two completed Phase 1 trials. NCT02303574 evaluated single and multiple ascending doses and food effect in 89 healthy volunteers. NCT02653872 assessed pharmacokinetics alone and with verapamil, itraconazole, or diltiazem in 15 healthy subjects.
AZD7986 is the primary name for this investigational compound. No alternative names have been reported for this drug in clinical trial records.