HealthyPhase 1NCT01349725
A Safety Study of ARRY-502 in Healthy Subjects
A Phase 1 study testing ARRY-502 in people with Healthy, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 1 site in United States.
Trial summary
This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ARRY-502
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2011to Sep 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female between the ages of 18 and 50 years.
- Females must be of nonchildbearing potential.
- Body mass index (BMI) of 18 to 32 and a total body weight > 50 kg (110 lbs) and < 114 kg (250 lbs).
- Additional criteria exist.
Who cannot join
- Evidence or history of clinically significant disease (excepting allergic rhinitis).
- Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Gastrointestinal surgery that may interfere with motility or absorption.
- Serious illness requiring hospitalization within the previous 6 months.
- A positive test for drugs or alcohol.
- Recent use of tobacco- or nicotine-containing products. Use of any medications, grapefruit or supplements within the previous 14 days.
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- Use of corticosteroids within the previous 28 days.
- Recent history of blood, plasma or platelet donation.
- Treatment with a small-molecule investigational drug within the previous 30 days or any biologic therapy within the previous 6 months.
- Prior exposure to investigational study drug ARRY-502.
- Additional criteria exist.
Trial locations and contacts
1 site in 1 country.
About this study
This is a Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.
- Conditions
- Healthy
- Being tested
- ARRY-502, Placebo
- Keywords
- Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARRY-502Drug
Oral; multiple dose, escalating
PlaceboDrug
Oral; matching placebo
| Study group | Role | What they receive |
|---|---|---|
| ARRY-502 | Experimental | Not described Receives: Drug: ARRY-502 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Measured: 3 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
Measured: 2 weeks
Secondary outcomes (1)
Characterize the pharmacodynamics of the study drug as determined by laboratory assays.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startMay 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349725
- Sponsor's protocol ID
- ARRAY-502-102
- Status last verified
- Sep 2020
- First submitted
- 5 May 2011
- Last updated
- 5 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety Study of ARRY-502 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01349725
- Acronym / sponsor ID
- ARRAY-502-102
- Conditions
- Healthy
- Keywords
- Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Array Biopharma, now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 9 May 2011 (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 Phase 1 study, involving a 14-day dosing period, designed to test the safety of investigational study drug ARRY-502 in healthy subjects. Approximately 32 healthy subjects from the United States will be enrolled in this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ARRY-502 | Experimental | Drug: ARRY-502 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female between the ages of 18 and 50 years.
- Females must be of nonchildbearing potential.
- Body mass index (BMI) of 18 to 32 and a total body weight > 50 kg (110 lbs) and < 114 kg (250 lbs).
- Additional criteria exist.
Key exclusion criteria (11 listed)
- Evidence or history of clinically significant disease (excepting allergic rhinitis).
- Evidence of hepatitis B, hepatitis C or human immunodeficiency virus (HIV).
- Gastrointestinal surgery that may interfere with motility or absorption.
- Serious illness requiring hospitalization within the previous 6 months.
- A positive test for drugs or alcohol.
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 |
|---|---|---|
| ARRY-502Oral; multiple dose, escalating | Drug | ARRY-502 |
| PlaceboOral; matching placebo | Drug | Placebo |
Primary outcome
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs.
Time frame: 3 weeks
Characterize the pharmacokinetics of the study drug and metabolite as determined by plasma concentrations.
Time frame: 2 weeks
1 secondary outcome
Characterize the pharmacodynamics of the study drug as determined by laboratory assays.
Time frame: 2 weeks
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 5 Oct 2020.
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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.
Pfizer CT.gov Call Center study director
Pfizer
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 ARRY-502 in people with Healthy, run by Array Biopharma, now a wholly owned subsidiary of Pfizer at 1 site in United States.
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 4 inclusion and 11 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 5 Oct 2020. 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 States. 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?
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests, electrocardiograms and vital signs. (time frame: 3 weeks). The study lists 2 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 5 Oct 2020.