Pharmacokinetics of AZD7295 Capsules

This study has been completed.
Sponsor:
Information provided by:
Arrow Therapeutics
ClinicalTrials.gov Identifier:
NCT01097408
First received: March 30, 2010
Last updated: August 6, 2010
Last verified: August 2010
  Purpose

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


Condition Intervention Phase
Healthy
Drug: AZD7295
Drug: Placebo comparator
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers

Further study details as provided by Arrow Therapeutics:

Primary Outcome Measures:
  • Pharmacokinetics of AZD7295 capsules [ Time Frame: 0-72h after each dose ] [ Designated as safety issue: No ]
    PK parameters of AZD7295 will be measured after single and repeated doses (AUC, Cmax, t1/2)


Secondary Outcome Measures:
  • Safety and tolerability of AZD7295 capsules [ Time Frame: 0-72h after each dose ] [ Designated as safety issue: Yes ]
    Safety and tolerability of AZD7295 will be assessed after single and repeated doses (adverse events, ECGs, vital signs, safety laboratory tests)


Enrollment: 12
Study Start Date: March 2010
Study Completion Date: August 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZD7295 Drug: AZD7295
Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.
Placebo Comparator: Matched placebo Drug: Placebo comparator
Placebo capsules

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous exposure to AZD7295, clinically relevant disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097408

Locations
United Kingdom
Quotient Clinical Research
Nottingham, United Kingdom
Sponsors and Collaborators
Arrow Therapeutics
Investigators
Principal Investigator: Jo Collier, Mb ChB Quotient Clinical Research
  More Information

No publications provided

Responsible Party: Liz Clark, Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT01097408     History of Changes
Other Study ID Numbers: HCV689-105
Study First Received: March 30, 2010
Last Updated: August 6, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on April 16, 2014