HealthyPhase 1NCT01474330
A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
A Phase 1 study testing Pomalidomide in people with Healthy, run by Celgene at 1 site in United States.
Trial summary
To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Pomalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2011to 1 Oct 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30
Who cannot join
- Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent Document (ICD), places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
- Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) Following Multiple Daily Doses in Healthy Male Subjects
To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
- Conditions
- Healthy
- Being tested
- Pomalidomide, Placebo
- Keywords
- Pomalidomide, safety, tolerability, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PomalidomideDrug
Also called CC-4047
0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| 0.5-mg Pomalidomide or placebo (Cohort A) | Experimental | A single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions Receives: Drug: Pomalidomide; Drug: Placebo |
| 1-mg Pomalidomide or placebo (Cohort B) | Experimental | This arm may be initiated pending a safety review of Cohort A. A single 1-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. Receives: Drug: Pomalidomide; Drug: Placebo |
| 2-mg Pomalidomide or placebo (Cohort C) | Experimental | This arm may be initiated pending a safety review of Cohort B. A single 2-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. Receives: Drug: Pomalidomide; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Number of participants with adverse events
Measured: 28 days after last dose
area under the plasma concentration-time curve
area under the plasma concentration-time curve
Measured: 72 hours after last dose
time to maximum observed plasma concentration
time to maximum observed plasma concentration
Measured: 72 hours after last dose
Secondary outcomes (4)
maximum observed plasma concentration
maximum observed plasma concentration
Measured: 72 hours after last dose
terminal elimination half-life
terminal elimination half-life
Measured: 72 hours after last dose
apparent total plasma clearance
apparent total plasma clearance
Measured: 72 hours after last dose
apparent total volume of distribution, and accumulation ratio
apparent total volume of distribution, and accumulation ratio
Measured: 72 hours after last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2011 (estimated)
- Study start1 Aug 2011
- Primary completion1 Oct 2011
- Study completion1 Oct 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.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celgene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Maria Palmisano, Study director, Celgene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01474330
- Sponsor's protocol ID
- CC-4047-CP-006
- Status last verified
- Nov 2019
- First submitted
- 16 Nov 2011
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) Following Multiple Daily Doses in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01474330
- Acronym / sponsor ID
- CC-4047-CP-006
- Conditions
- Healthy
- Keywords
- Pomalidomide, safety, tolerability, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- CelgeneIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2011 (actual)
- Primary completion
- 1 Oct 2011 (actual)
- Study completion
- 1 Oct 2011 (actual)
- First posted
- 18 Nov 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.
To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0.5-mg Pomalidomide or placebo (Cohort A) | Experimental | Drug: Pomalidomide, Drug: PlaceboA single 0.5-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions |
| 1-mg Pomalidomide or placebo (Cohort B) | Experimental | Drug: Pomalidomide, Drug: PlaceboThis arm may be initiated pending a safety review of Cohort A. A single 1-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. |
| 2-mg Pomalidomide or placebo (Cohort C) | Experimental | Drug: Pomalidomide, Drug: PlaceboThis arm may be initiated pending a safety review of Cohort B. A single 2-mg pomalidomide capsule or matching placebo administered once daily for 5 days under fasted conditions. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30
Key exclusion criteria (3 listed)
- Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent Document (ICD), places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
- Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
- Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).
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 |
|---|---|---|
| PomalidomideAlso: CC-40470.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions | Drug | 0.5-mg Pomalidomide or placebo (Cohort A), 1-mg Pomalidomide or placebo (Cohort B), 2-mg Pomalidomide or placebo (Cohort C) |
| PlaceboPlacebo capsule | Drug | 0.5-mg Pomalidomide or placebo (Cohort A), 1-mg Pomalidomide or placebo (Cohort B), 2-mg Pomalidomide or placebo (Cohort C) |
Primary outcome
Number of participants with adverse events
Time frame: 28 days after last dose
Number of participants with adverse events
area under the plasma concentration-time curve
Time frame: 72 hours after last dose
area under the plasma concentration-time curve
time to maximum observed plasma concentration
Time frame: 72 hours after last dose
time to maximum observed plasma concentration
4 secondary outcomes
maximum observed plasma concentration
Time frame: 72 hours after last dose
terminal elimination half-life
Time frame: 72 hours after last dose
apparent total plasma clearance
Time frame: 72 hours after last dose
apparent total volume of distribution, and accumulation ratio
Time frame: 72 hours after last 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 12 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 study director
Celgene
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 Pomalidomide 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 3 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 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. 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?
Number of participants with adverse events (time frame: 28 days after last 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 Nov 2019.