Clinical Pharmacology Study of AZD7295 in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Arrow Therapeutics
ClinicalTrials.gov Identifier:
NCT00906256
First received: May 11, 2009
Last updated: February 11, 2010
Last verified: February 2010
  Purpose

The purpose of this study is to determine the pharmacokinetic profile of oral doses of AZD7295 capsules in healthy subjects, and also to assess the effects of food as well as safety and tolerability.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects

Further study details as provided by Arrow Therapeutics:

Primary Outcome Measures:
  • To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects. [ Time Frame: PK samples at pre-dose, 0.5h, 1.0h, 1.5h, 2.0h, 2.5h, 3.0h, 4.0h, 6.0h, 12.0h and 24.0h post dose. ] [ Designated as safety issue: No ]
  • To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295 capsules in healthy subjects [ Time Frame: 1st two treatment days of study ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability profiles of oral doses of AZD7295 in healthy subjects. [ Time Frame: at each dosing day ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: April 2009
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AZD7295
AZD7295
Drug: AZD7295
Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.
Placebo Comparator: Placebo capsule
Placebo
Drug: Placebo
Placebo

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Healthy males or healthy females of non-child bearing potential
  2. Aged 18-65 years;
  3. Body Mass Index (BMI) of 18-32kg/m2;
  4. Normal electrocardiograms (ECGs) or with clinically insignificant abnormalities in the opinion of the Investigator;
  5. Normal vital signs or with clinically insignificant abnormalities in the opinion of the Investigator;
  6. Clinically normal physical findings and safety laboratory values at the time of the screening visit, as judged by the Investigator;
  7. Must be willing and able to participate in the whole study and must provide written informed consent.

Exclusion Criteria:

  1. Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months;
  2. Subjects who have previously been enrolled in this study;
  3. A past or current disease, which as judged by the Investigator, could affect the subject's participation in or the outcome of the study. These diseases include, but are not limited to cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, immunological disease and endocrine disease;
  4. Subjects who have ever sought advice from or been referred to a GP or counsellor for abuse or misuse of alcohol, non medical drugs, medicinal drugs or other substance abuse e.g. solvents;
  5. Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months;);
  6. Positive drugs of abuse test result (Appendix 1, Section 20);
  7. Regular alcohol consumption in males >21 units per week and females >14 units per week (1 Unit = ½ pint beer, a 25 mL shot of 40% spirit or a 125 mL glass of wine);
  8. Smoking of more than 10 cigarettes per day and the inability to refrain from smoking during confinement;
  9. Females of child bearing potential, as detailed in Section 9.4;
  10. Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the PI (Appendix 1, Section 20);
  11. History of adverse reaction or allergy to study drug or its excipients. If the subject suffers from hayfever they must not have or be expecting to have symptoms during the study period;
  12. Subjects with known present or past medical history, or family history (as far as known by the subject) of any of the following cardiovascular findings:

    • 2nd degree AV-block (type II) or 3rd degree AV-block and/or other relevant arrhythmias
    • Prolonged QT-interval syndrome or other cardiac conduction disorder QTc > 450 ms
    • PR interval outside range of 120 - 220 ms
    • Evidence of clinically significant T wave abnormalities
  13. Donation of blood within the previous three months;
  14. Subjects will be excluded from the study if they are considered by the PI to be at risk of transmitting, thorough blood or other body fluids, the agents responsible for acquired immunodeficiency syndrome (AIDS) or other sexually transmitted disease or hepatitis;
  15. Positive HBV, HCV or HIV results;
  16. Excessive use of caffeine (more than five cups of coffee or equivalent per day);
  17. Subjects receiving prohibited medication as described in Section 9.5;
  18. Subjects with planned surgery, dental procedure or hospitalisation during the study;
  19. Failure to satisfy the PI of fitness to participate for any other reason.
  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: NCT00906256

Locations
United Kingdom
Pharmaceutical Profiles Ltd
Nottingham, United Kingdom, NG11 6JS
Sponsors and Collaborators
Arrow Therapeutics
  More Information

No publications provided

Responsible Party: Dr Joanne Collier, Pharmaceutical Profiles Ltd
ClinicalTrials.gov Identifier: NCT00906256     History of Changes
Other Study ID Numbers: HCV689-103
Study First Received: May 11, 2009
Last Updated: February 11, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Arrow Therapeutics:
Hepatitis C
Pharmacokinetics
AZD7295
Healthy volunteers

ClinicalTrials.gov processed this record on August 26, 2014