MedTrace Logo

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

NCT02484729 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2017-04-28

Study results available
· View outcomes & findings →

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.

Conditions

  • Safety
  • Tolerability
  • Pharmacokinetics
  • Healthy Subjects

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Muna Albayaty, Dr. · PAREXEL Early Phase Clinical Unit London, Level 7, Northwick Park Hospital, Watford Road, Harrow, Middlesex HA1 3UJ, United Kingdom

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02484729 on ClinicalTrials.gov