Pharmacokinetics of AZD7295 Capsules

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: AZD7295; Drug: Placebo comparator

• Registration Number: NCT01097408
• Lead Sponsor: Arrow Therapeutics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-30
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Primary Completion: 2010-05
• Status Verified: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2010-08-06
• Last Update Posted: 2010-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

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

Exclusion Criteria

• Previous exposure to AZD7295, clinically relevant disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AZD7295	AZD7295	-
Matched placebo	Placebo comparator	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Quotient Clinical Research; 🇬🇧 Nottingham, United Kingdom