- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00906256
Clinical Pharmacology Study of AZD7295 in Healthy Subjects
A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects
Study Overview
Detailed Description
OBJECTIVES: Primary
- To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects
- To study the effect of food on the pharmacokinetic profiles of oral doses of AZD7295 capsules in healthy subjects
- To assess the safety and tolerability profiles of oral daily doses of AZD7295 capsules in healthy subjects TYPE AND DESIGN: Part A A phase I, single-centre, double-blind, randomised, placebo-controlled, crossover, food effect study in healthy subjects
Part B A phase I, single-centre, double-blind, randomised, placebo-controlled, ascending dose study in healthy subjects
NUMBER OF SUBJECTS: 16 subjects will take part in a total of 4 treatment periods.
SUBJECT CHARACTERISTICS: Healthy males and females of non-child bearing potential aged 18 to 65 years.
Recruitment will not be balanced for gender or any other variable.
TREATMENT: Part A
Subjects will be randomised to receive AZD7295 or placebo (14 active; 2 placebo) in either the fed or fasted state according to the treatment allocation:
Treatment A: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fed state
Treatment B: 260 mg (4 x 65 mg) AZD7295 capsules or placebo dosed in the fasted state
Following dosing of the first two periods there will be a period of interim analysis, during which the pharmacokinetic data will be reviewed in order to determine whether the remaining treatments will be dosed either in the fed or fasted state.
Subjects from Part A will continue into Part B of the study.
Part B
Subjects will be allocated to two groups of n=8 (Group 1 and Group 2) and randomised to receive AZD7295 or placebo (6 active; 2 placebo). Subjects will receive two of the ascending dose treatments in the following order according to group allocation:
Group 1:
Treatment C: 455 mg (7 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;
Group 2:
Treatment D: 650 mg (10 x 65 mg) AZD7295 or placebo dosed either in the fed or fasted state;
Group 1:
Treatment E: 650 mg (10 x 65 mg) AZD7295 or placebo, twice a day (q12h) dosed either in the fed or fasted state (total administered dose: 1300 mg);
Group 2:
Treatment F: 650 mg (10 x 65 mg) AZD7295 or placebo, three times a day (q8h) dosed either in the fed or fasted state (total administered dose: 1950 mg).
Safety data and limited PK data will be reviewed by the data review group prior to proceeding to the next dose level.
During the dose escalation phase a maximum of 4 subjects will be dosed per day.
MAIN OUTCOME MEASURES: The primary outcome will be to determine the pharmacokinetic profiles of AZD7295 when dosed in the fed and fasted state and to assess the safety and tolerability of higher daily doses of AZD7295.
GENERAL SCHEDULE: Screening is planned to start in April 2009, with the clinical phase due to be completed by the end of July 2009
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Nottingham, United Kingdom, NG11 6JS
- Pharmaceutical Profiles Ltd
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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:
- 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
- Donation of blood within the previous three months;
- 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;
- Positive HBV, HCV or HIV results;
- Excessive use of caffeine (more than five cups of coffee or equivalent per day);
- Subjects receiving prohibited medication as described in Section 9.5;
- Subjects with planned surgery, dental procedure or hospitalisation during the study;
- Failure to satisfy the PI of fitness to participate for any other reason.
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: AZD7295
|
Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.
|
Placebo Comparator: Placebo capsule
Placebo
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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
Time Frame: 1st two treatment days of study
|
1st two treatment days of study
|
To assess the safety and tolerability profiles of oral doses of AZD7295 in healthy subjects.
Time Frame: at each dosing day
|
at each dosing day
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HCV689-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States