Clinical Pharmacology Study of AZD7295 in Healthy Subjects

NCT00906256 | Completed Phase 1 DMC

• 1 other identifier: HCV689-103
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Hepatitis C; Pharmacokinetics; AZD7295; Healthy volunteers

Outcome Measures

Primary Outcomes (3)

• To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects.

  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.

• To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295 capsules in healthy subjects

  1st two treatment days of study

• To assess the safety and tolerability profiles of oral doses of AZD7295 in healthy subjects.

  at each dosing day

Study Arms (2)

AZD7295

ACTIVE COMPARATOR

AZD7295

Drug: AZD7295

Placebo capsule

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

AZD7295 DRUG

Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.

AZD7295

Placebo DRUG

Placebo

Placebo capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months;
• Subjects who have previously been enrolled in this study;
• 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;
• 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;
• 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;);
• Positive drugs of abuse test result (Appendix 1, Section 20);
• 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);
• Smoking of more than 10 cigarettes per day and the inability to refrain from smoking during confinement;
• Females of child bearing potential, as detailed in Section 9.4;
• Clinically significant abnormal biochemistry, haematology or urinalysis as judged by the PI (Appendix 1, Section 20);
• 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;
• 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:
• nd 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

Sponsors & Collaborators

• Arrow Therapeutics: lead

Study Sites (1)

Pharmaceutical Profiles Ltd

Nottingham, NG11 6JS, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 11, 2009
• First Posted: May 21, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: February 12, 2010

Record last verified: 2010-02

Locations

GB (1)