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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014