HealthyPhase 1NCT01692184
Safety and Pharmacokinetics of AVL-292 Following Multiple Doses and the Effect of Food on the Single-dose Pharmacokinetics of AVL-292
A Phase 1 study testing 50 mg AVL-292, 100 mg AVL-292 and 200 mg AVL-292 in people with Healthy, run by Celgene at 1 site in United States.
Trial summary
This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292. 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?
- 50 mg AVL-292, 100 mg AVL-292 and 200 mg AVL-292
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2012to 8 Oct 2012
- 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 subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33
Who cannot join
- Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, ophthalmological, allergic or other major disorders;
- Use of any prescribed systemic or topical medication within 30 days of the first dose;
- Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first dose administration;
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Two-part Study to Investigate the Safety and Pharmacokinetics of AVL-292 Following Multiple Oral Doses and to Evaluate the Effect of Food on the Pharmacokinetics of AVL-292 Following a Single Oral Dose in Healthy Adult Subjects
This is a 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.
Read the detailed description
Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.
- Conditions
- Healthy
- Being tested
- 50 mg AVL-292, 100 mg AVL-292, 200 mg AVL-292, 350 mg AVL-292, Placebo capsules
- Keywords
- AVL-292, Safety, Pharmacokinetics, Pharmacodynamics, Pharmacology, Clinical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 mg AVL-292Drug
Also called AVL-292
100 mg AVL-292Drug
Also called AVL-292
200 mg AVL-292Drug
Also called AVL-292
350 mg AVL-292Drug
Also called AVL-292
Placebo capsulesDrug
| Study group | Role | What they receive |
|---|---|---|
| 50 mg of AVL-292 and Placebo | Experimental | 50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition Receives: Drug: 50 mg AVL-292; Drug: Placebo capsules |
| 100 mg of AVL-292 and Placebo | Experimental | 100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition Receives: Drug: 100 mg AVL-292; Drug: Placebo capsules |
| 200 mg AVL-292 | Experimental | 8 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition Receives: Drug: 200 mg AVL-292 |
| 350 mg of AVL-292 | Experimental | 350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition Receives: Drug: 350 mg AVL-292 |
| Placebo - 8 capsules | Placebo comparator | 8 placebo capsules once daily for 7 days administered orally under fasted condition Receives: Drug: Placebo capsules |
| Placebo - 14 capsules | Placebo comparator | 14 placebo capsules once daily for 7 days administered orally under fasted condition Receives: Drug: Placebo capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants with adverse events
Measured: Up to 28 days after last AVL-292 dose
PK-(Cmax)
Maximum observed concentration in plasma
Measured: 24 hours after the last AVL-292 dose on days 1 and 7
PK-(AUC)
Area under the plasma concentration-time curve
Measured: 24 hours after the last AVL-292 dose days 1 and 7
Secondary outcomes (1)
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
Measured: 24 hours after the last AVL-292 dose days 1 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study start1 Aug 2012
- Primary completion8 Oct 2012
- Study completion8 Oct 2012
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.
- More trials run by CelgeneThe sponsor's other registered studies.
- 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
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, MD, Study director, Celgene Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692184
- Sponsor's protocol ID
- AVL-292-004
- Status last verified
- Oct 2019
- First submitted
- 21 Sep 2012
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Two-part Study to Investigate the Safety and Pharmacokinetics of AVL-292 Following Multiple Oral Doses and to Evaluate the Effect of Food on the Pharmacokinetics of AVL-292 Following a Single Oral Dose in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT01692184
- Acronym / sponsor ID
- AVL-292-004
- Conditions
- Healthy
- Keywords
- AVL-292, Safety, Pharmacokinetics, Pharmacodynamics, Pharmacology, Clinical
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2012 (actual)
- Primary completion
- 8 Oct 2012 (actual)
- Study completion
- 8 Oct 2012 (actual)
- First posted
- 25 Sep 2012 (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 2-part study. The first part is to evaluate the safety, pharmacokinetics (PK) and pharmacodynamics of AVL-292 following multiple oral doses; and the second part is to evaluate the effect of food on the pharmacokinetics of a single oral dose of AVL-292.
Detailed description
Part 2 is an open-label, randomized, 2-period, 2-way crossover study to evaluate the effect of a standard high-fat breakfast on the pharmacokinetics of AVL-292. Ten subjects will be enrolled to receive 2 single doses of 200 mg AVL-292, one with food (i.e., fed) and the other without (i.e., fasted), in a randomized sequence.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 50 mg of AVL-292 and Placebo | Experimental | Drug: 50 mg AVL-292, Drug: Placebo capsules50 mg AVL-292 (2 x 25 mg AVL-292 capsules and 6 placebo capsules) once daily for 7 days administered orally under fasted condition |
| 100 mg of AVL-292 and Placebo | Experimental | Drug: 100 mg AVL-292, Drug: Placebo capsules100 mg AVL-292 (4 x 25 mg AVL-292 capsules and 4 placebo capsules) once daily for 7 days administered orally under fasted condition |
| 200 mg AVL-292 | Experimental | Drug: 200 mg AVL-2928 x 25 mg AVL-292 capsules orally once daily for 7 days under fasted condition |
| 350 mg of AVL-292 | Experimental | Drug: 350 mg AVL-292350 mg AVL-292 (14 x 25 mg AVL-292 capsules) once daily for 7 days administered orally under fasted condition |
| Placebo - 8 capsules | Placebo comparator | Drug: Placebo capsules8 placebo capsules once daily for 7 days administered orally under fasted condition |
| Placebo - 14 capsules | Placebo comparator | Drug: Placebo capsules14 placebo capsules once daily for 7 days administered orally under fasted condition |
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 subjects of any ethnic origin between ages of 18 and 65 with a body mass index between 18 and 33
Key exclusion criteria (4 listed)
- Recent history (i.e., within 3 years) of any clinically significant neurological, gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, endocrine, hematological, dermatological, psychological, ophthalmological, allergic or other major disorders;
- Use of any prescribed systemic or topical medication within 30 days of the first dose;
- Use of any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines, e.g., St. John's Wort) within 7 days of the first dose administration;
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration
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 |
|---|---|---|
| 50 mg AVL-292Also: AVL-292 | Drug | 50 mg of AVL-292 and Placebo |
| 100 mg AVL-292Also: AVL-292 | Drug | 100 mg of AVL-292 and Placebo |
| 200 mg AVL-292Also: AVL-292 | Drug | 200 mg AVL-292 |
| 350 mg AVL-292Also: AVL-292 | Drug | 350 mg of AVL-292 |
| Placebo capsules | Drug | 100 mg of AVL-292 and Placebo, 50 mg of AVL-292 and Placebo, Placebo - 14 capsules, Placebo - 8 capsules |
Primary outcome
Adverse Events
Time frame: Up to 28 days after last AVL-292 dose
Number of participants with adverse events
PK-(Cmax)
Time frame: 24 hours after the last AVL-292 dose on days 1 and 7
Maximum observed concentration in plasma
PK-(AUC)
Time frame: 24 hours after the last AVL-292 dose days 1 and 7
Area under the plasma concentration-time curve
1 secondary outcome
Pharmacodynamic response measured in percentage of target occupancy by AVL-292 in peripheral blood mononuclear cells
Time frame: 24 hours after the last AVL-292 dose days 1 and 7
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 4 Nov 2019.
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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.
Maria Palmisano, MD study director
Celgene Corporation
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 50 mg AVL-292, 100 mg AVL-292 and 200 mg AVL-292 in people with Healthy, run by Celgene 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 1 inclusion and 4 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 4 Nov 2019. 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?
Adverse Events (time frame: Up to 28 days after last AVL-292 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 4 Nov 2019.