NCT02560363

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

An Open-label, Randomized, Cross Over Single Oral Dose Study Comparing the Pharmacokinetics of Different Formulations of AZD9977 (Part A) and Influence of Food (Part B) in Healthy Male Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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

Detailed description

This is an open-label, randomized, cross over single oral dose study to compare the pharmacokinetics of three different extended-release formulations and an immediate-release formulation (reference) 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

Type	Name	Description
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

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-01-01
• Completion: 2016-01-01
• First posted: 2015-09-25
• Last updated: 2016-01-11

Locations

1 site across 1 country: United Kingdom