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Pharmacokinetics of AZD7295 Capsules

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01097408
First Posted: April 1, 2010
Last Update Posted: August 9, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Arrow Therapeutics
  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: Triple (Participant, Care Provider, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Liz Clark, Arrow Therapeutics
ClinicalTrials.gov Identifier: NCT01097408     History of Changes
Other Study ID Numbers: HCV689-105
First Submitted: March 30, 2010
First Posted: April 1, 2010
Last Update Posted: August 9, 2010
Last Verified: August 2010