Healthy Subjects Clinical Trial
Official title:
An Open-label, Non-randomized, Fixed Sequence Study Assessing the Pharmacokinetics of AZD7986 When Administered Alone and With Multiple Doses of Verapamil and Itraconazole or Diltiazem in Healthy Subjects
This is a phase 1, non-randomized, fixed sequence, 3-period, drug-drug interaction study to assess the pharmacokinetics (PK) of AZD7986 in healthy subjects when administered alone and in combination with multiple doses of verapamil and itraconazole or diltiazem
This study will be an open-label, non-randomised, fixed sequence, 3-period study conducted at
a single study centre to assess the PK of AZD7986 in healthy subjects when administered alone
and in combination with multiple doses of verapamil and itraconazole or diltiazem. An
adaptive design with an interim analysis of the PK data from Periods 1 and 2 will be used to
determine which of itraconazole or diltiazem will be administered in combination with AZD7986
in Period 3.
Treatments to be administered in a fixed order separated by a washout period:
period 1 - single AZD7986 (25 mg) on Day 1 (1 hour before food), washout 7 days period 2 -
verapamil (240 mg extended release formulation) daily 1 hour before food (Day 1 to 10) and a
single dose of AZD7986 (25 mg) 1 hour before food (Day 5), washout period 14 days period 3 -
subject to interim pharmacokinetic analysis of AZD7986 alone compared with AZD7986 and
verapamil combined, either itraconazole (200 mg, oral solution formulation 10mg/mL)
administered twice on Day 1 and daily on days 2 to 11 (1 hour before food) plus AZD7986
(25mg) single dose on Day 6 (1 hour before food); or diltiazem (360 mg, extended release
formulation) on Days 1 to 13 (1 hour before food) plus AZD7986 (25 mg) 1 hour before food on
Day 8.
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