HealthyPhase 1NCT00906256
Clinical Pharmacology Study of AZD7295 in Healthy Subjects
A Phase 1 study testing AZD7295 in people with Healthy, run by Arrow Therapeutics at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- AZD7295
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2009to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
Show all 23Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects
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.
Read the 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
- Conditions
- Healthy
- Being tested
- AZD7295, Placebo
- Keywords
- Hepatitis C, Pharmacokinetics, AZD7295, Healthy volunteers
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7295Drug
Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| AZD7295 | Active comparator | AZD7295 Receives: Drug: AZD7295 |
| Placebo capsule | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the pharmacokinetic profiles of oral doses of AZD7295 capsules administered to healthy subjects.
Measured: 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
Measured: 1st two treatment days of study
To assess the safety and tolerability profiles of oral doses of AZD7295 in healthy subjects.
Measured: at each dosing day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2009 (estimated)
- Study startApr 2009
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrow Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00906256
- Sponsor's protocol ID
- HCV689-103
- Status last verified
- Feb 2010
- First submitted
- 11 May 2009
- Last updated
- 12 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacology Study to Determine the Pharmacokinetic, Safety and Tolerability Profile of Oral Doses of AZD7295 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00906256
- Acronym / sponsor ID
- HCV689-103
- Conditions
- Healthy
- Keywords
- Hepatitis C, Pharmacokinetics, AZD7295, Healthy volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Arrow TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 21 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7295 | Active comparator | Drug: AZD7295AZD7295 |
| Placebo capsule | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AZD7295Capsules 260mg, 455mg, 650mg (single doses), 650mg q12h, 650mg q8h. | Drug | AZD7295 |
| PlaceboPlacebo | Drug | Placebo capsule |
Primary outcome
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.
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
To assess the safety and tolerability profiles of oral doses of AZD7295 in healthy subjects.
Time frame: at each dosing day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AZD7295 in people with Healthy, run by Arrow Therapeutics at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2010.