NCT02484729

A Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD9977 After Single Ascending Doses to Healthy Males

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Access the Safety, Tolerability and Pharmacokinetics of AZD9977 Following Single Ascending Dose Administration to Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Safety
• Tolerability
• Pharmacokinetics
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	AZD9977, oral suspension	Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B)
DRUG	Placebo, oral suspension	Matching placebo
DRUG	AZD9977, oral solution	AZD9977, single dose of oral solution in Part B as reference

Timeline

• Start date: 2015-07-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2015-06-30
• Last updated: 2017-04-28
• Results posted: 2017-03-24

Locations

1 site across 1 country: United Kingdom