HealthyPhase 1NCT01097408
Pharmacokinetics of AZD7295 Capsules
A Phase 1 study testing AZD7295 in people with Healthy, run by Arrow Therapeutics at 1 site in United Kingdom.
Trial summary
This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers. 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
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2010to Aug 2010
- 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 male or female volunteers, aged 18-65 years.
Who cannot join
- Previous exposure to AZD7295, clinically relevant disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers
This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.
- Conditions
- Healthy
- Being tested
- AZD7295, Placebo comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZD7295Drug
Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.
Placebo comparatorDrug
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| AZD7295 | Experimental | Not described Receives: Drug: AZD7295 |
| Matched placebo | Placebo comparator | Not described Receives: Drug: Placebo comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of AZD7295 capsules
PK parameters of AZD7295 will be measured after single and repeated doses (AUC, Cmax, t1/2)
Measured: 0-72h after each dose
Secondary outcomes (1)
Safety and tolerability of AZD7295 capsules
Safety and tolerability of AZD7295 will be assessed after single and repeated doses (adverse events, ECGs, vital signs, safety laboratory tests)
Measured: 0-72h after each dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionMay 2010
- Study completionAug 2010
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrow Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jo Collier, Mb ChB, Principal investigator, Quotient Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097408
- Sponsor's protocol ID
- HCV689-105
- Status last verified
- Aug 2010
- First submitted
- 30 Mar 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-Blind, Placebo-Controlled Study to Determine the Pharmacokinetics, Safety and Tolerability of AZD7295 Capsules in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01097408
- Acronym / sponsor ID
- HCV689-105
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Arrow TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- May 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Apr 2010 (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.
This is a pharmacokinetics (PK) and safety study of AZD7295 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AZD7295 | Experimental | Drug: AZD7295 |
| Matched placebo | Placebo comparator | Drug: Placebo comparator |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male or female volunteers, aged 18-65 years.
Key exclusion criteria (1 listed)
- Previous exposure to AZD7295, clinically relevant disease.
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 |
|---|---|---|
| AZD7295Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days. | Drug | AZD7295 |
| Placebo comparatorPlacebo capsules | Drug | Matched placebo |
Primary outcome
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)
1 secondary outcome
Safety and tolerability of AZD7295 capsules
Time frame: 0-72h after each dose
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 9 Aug 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.
Jo Collier, Mb ChB principal investigator
Quotient Clinical Research
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 1 inclusion and 1 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 9 Aug 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?
Pharmacokinetics of AZD7295 capsules (time frame: 0-72h after each dose). 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 9 Aug 2010.