MedTrace Logo

A Study to Compare the Pharmacokinetics of Different Formulations of AZD9977 and the Influence of Food in Healthy Male Subjects

NCT02560363 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-01-11

No results posted yet for this study

Summary

This is an open-label, randomized, cross over single oral dose study to compare the pharmacokinetics of different formulations of AZD9977 in Part A and the influence of food in Part B in healthy male subjects

Conditions

  • Pharmacokinetics
  • Healthy Male Subjects
  • Safety
  • Food Effect

Interventions

DRUG

AZD9977 immediate release (IR) oral suspension

120 mg (4.8 mL x 25 mg/mL) oral suspension, single dose

DRUG

AZD9977 extended release (ER) capsules [fast]

120 mg (2 x 60mg capsules) single dose

DRUG

AZD9977 extended release (ER) capsules [intermediate]

120 mg (2 x 60mg capsules) single dose

DRUG

AZD9977 extended release (ER) capsules [slow]

120 mg (2 x 60mg capsules) single dose

Sponsors & Collaborators

Principal Investigators

  • Muna Albayaty, MBChB, MSc, MFPM · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2016-01-31
Completion
2016-01-31

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 NCT02560363 on ClinicalTrials.gov