CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 196 enrolled
Drug / intervention
AZD9977, oral suspension +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02484729
NCT02484729Phase 1Completed
CompareCT.gov

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

AstraZeneca·interventional·Posted Jun 30, 2015·Updated Apr 28, 2017

In Brief

A Phase 1 clinical trial evaluating AZD9977, oral suspension, Placebo, oral suspension, and 1 other intervention for Safety and 3 related conditions. Completed, enrolled 196 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSafety, Tolerability, Pharmacokinetics, Healthy Subjects
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJun 30, 2015
Enrollment StartJul 1, 2015
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.0 years ago

Interventions

AZD9977, oral suspensiondrug

Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B)

Placebo, oral suspensiondrug

Matching placebo

AZD9977, oral solutiondrug

AZD9977, single dose of oral solution in Part B as reference