Pharmacokinetics of AZD7295 Capsules

A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers

This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: AZD7295; Drug: Placebo comparator

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Nottingham, United Kingdom
    • Quotient Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy male or female volunteers, aged 18-65 years.

Exclusion Criteria:

• Previous exposure to AZD7295, clinically relevant disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matched placebo	Drug: Placebo comparator; Placebo capsules
Experimental: AZD7295	Drug: AZD7295; Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics of AZD7295 capsules	PK parameters of AZD7295 will be measured after single and repeated doses (AUC, Cmax, t1/2)	0-72h after each dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability of AZD7295 capsules	Safety and tolerability of AZD7295 will be assessed after single and repeated doses (adverse events, ECGs, vital signs, safety laboratory tests)	0-72h after each dose

Collaborators and Investigators

• Sponsor: Arrow Therapeutics
• Investigators: Principal Investigator: Jo Collier, Mb ChB, Quotient Clinical Research

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: March 30, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 1, 2010

Study Record Updates

• Last Update Posted (Estimate): August 9, 2010
• Last Update Submitted That Met QC Criteria: August 6, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Other Study ID Numbers: HCV689-105