Conditions: Safety, Pharmacokinetics, Pharmacodynamics, Food Effect
Keywords: AZD7986, Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Food Effect, First-in-human, Single Ascending Dose, Multiple Ascending Dose, Healthy Subjects
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 89
Healthy volunteers: yes

Brief summary:
This is a phase I, randomised, single-blind placebo-controlled, 2-part study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of single and multiple oral doses of AZD7986 in healthy volunteers

Detailed description:

Arms:
arm 1: In Part 1 up to 8 cohorts with single doses starting with 5 mg AZD7986 as oral solution. In Part 2 up to 5 cohorts with multiple doses of AZD7986 as oral solution arm 2: In Part 1 up to 8 cohorts and in Part 2 up to 5 cohorts with matching placebo to AZD7986 as oral solution

Interventions: intervention 1: AZD7986, oral solution, 1 to 50 mg/mL intervention 2: Placebo, oral solution
Intervention descriptions: intervention 1: Starting dose in single ascending dose part: 5 mg intervention 2: Matching placebo

Protocol document: