Conditions: Safety Tolerability Pharmacokinetics Healthy Subjects
Keywords: AZD9977 Safety Tolerability Pharmacokinetics First-in-human Single Ascending Dose Regional absorption Healthy male subjects
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 196
Healthy volunteers: yes

Brief summary:
This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design. The study will be performed at a single study centre.

Detailed description:
This study will be a randomized, single-blind, placebo-controlled first-in-human study in healthy male subjects to assess the safety, tolerability and pharmacokinetics of single ascending doses of AZD9977. In Part B of this study the regional absorption of AZD9977 along the gastro-intestinal tract will be investigated using the IntelliCap® system in a non-randomized, open-label, fixed-sequence design with oral solution as reference. The study will be performed at a single study centre.

Arms:
arm 1: In Part A up to 10 cohorts with single ascending doses with AZD9977 as oral suspension. In Part B AZD9977 as oral suspension in IntelliCap® capsule arm 2: In Part A up to 10 cohorts with single doses with matching placebo to AZD9977 arm 3: In Part B, of oral solution of AZD9977 will be used as reference

Interventions: intervention 1: AZD9977, oral suspension intervention 2: Placebo, oral suspension intervention 3: AZD9977, oral solution
Intervention descriptions: intervention 1: Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B) intervention 2: Matching placebo intervention 3: AZD9977, single dose of oral solution in Part B as reference

Protocol document: