HealthyPhase 1NCT01616277
A Phase 1 Study To Evaluate The Safety And Tolerability Of PF-06252616 In Healthy Subjects
A Phase 1 study testing PF-06252616 and PF-06252161 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06252616 and PF-06252161
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Aug 2014
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
- Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.
Who cannot join
- Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
- Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.
- Conditions
- Healthy
- Being tested
- PF-06252616, Placebo, PF-06252161
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06252616Biological
1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
PlaceboDrug
Placebo for PF-06252616, IV infusion, single dose
PF-06252616Biological
3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
PlaceboDrug
Placebo for PF-06252616, IV infusion, single dose
PF-06252161Biological
10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
PlaceboDrug
Placebo for PF-06252616, IV infusion, single dose
PF-06252616Biological
3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
PlaceboDrug
Placebo for PF-06252616, Subcutaneous injection, single dose
PF-06252616Biological
10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
PlaceboDrug
Placebo for PF-06252616, IV infusion, repeat dose
PF-06252616Biological
20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
PlaceboDrug
Placebo for PF-06252616, IV infusion, single dose
PF-06252616Biological
40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
PlaceboDrug
Placebo for PF-06252616, IV infusion, single dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Biological: PF-06252616; Drug: Placebo |
| 2 | Placebo comparator | Not described Receives: Biological: PF-06252616; Drug: Placebo |
| 3 | Placebo comparator | Not described Receives: Biological: PF-06252161; Drug: Placebo |
| 4 | Placebo comparator | Not described Receives: Biological: PF-06252616; Drug: Placebo |
| 5 | Placebo comparator | Repeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram Receives: Biological: PF-06252616; Drug: Placebo |
| 6 | Placebo comparator | Not described Receives: Biological: PF-06252616; Drug: Placebo |
| 7 | Placebo comparator | Not described Receives: Biological: PF-06252616; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment related Adverse Events.
Measured: Day 197
Severity of treatment related Adverse Events.
Measured: Day 197
Incidence of abnormal lab findings.
Measured: Day 197
Magnitude of abnormal lab findings.
Measured: Day 197
Abnormal and clinically relevant changes in Blood Pressure.
Measured: Day 197
Abnormal and clinically relevant changes in Pulse Rate.
Measured: Day 197
Abnormal and clinically relevant changes in Respiratory Rate.
Measured: Day 197
Abnormal and clinically relevant changes in temperature.
Measured: Day 197
Abnormal and clinically relevant changes in ECG parameters.
Measured: Day 197
Secondary outcomes (16)
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Measured: Through Day 197 post dosing
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
Measured: Through Day 197 post dosing
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Measured: Through Day 197 post dosing
Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA
Measured: Through Day 113 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half).
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.
Measured: Through Day 197 post dosing
Steady state volume of distribution is the apparent volume of distribution at steady-state.)
Measured: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)
Measured: Through Day 197 post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 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
- NCT01616277
- Sponsor's protocol ID
- B5161001
- Status last verified
- Sep 2014
- First submitted
- 25 May 2012
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wojciechowski J, Purohit VS, Harnisch LO, Dua P, Tan B, Nicholas T. Population PK and PD Analysis of Domagrozumab in Pediatric Patients with Duchenne Muscular Dystrophy. Clin Pharmacol Ther. 2022 Dec;112(6):1291-1302. doi: 10.1002/cpt.2747. Epub 2022 Oct 4.
PubMed 36104012
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. 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, Pharmacokinetics And Pharmacodynamics Of PF-06252616 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT01616277
- Acronym / sponsor ID
- B5161001
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Jun 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.
The purpose of this study is to determine if the study drug, PF-06252616 is safe and well tolerated when given to adult healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Biological: PF-06252616, Drug: Placebo |
| 2 | Placebo comparator | Biological: PF-06252616, Drug: Placebo |
| 3 | Placebo comparator | Biological: PF-06252161, Drug: Placebo |
| 4 | Placebo comparator | Biological: PF-06252616, Drug: Placebo |
| 5 | Placebo comparator | Biological: PF-06252616, Drug: PlaceboRepeat dose of PF-06252616, IV infusion, single dose - 10.0 miligram per kilogram |
| 6 | Placebo comparator | Biological: PF-06252616, Drug: Placebo |
| 7 | Placebo comparator | Biological: PF-06252616, Drug: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Single Dose Cohorts-Healthy male and/or female non-child bearing subjects between the ages of 18 and 55 years, inclusive.
- Repeat Dose Cohort-Healthy male and/or female non-child bearing subjects between the ages of 18 and less than 65 years, inclusive.
Key exclusion criteria (3 listed)
- Presence or history of muscle disease (eg, polymyositis or rhabdomyolysis).
- Weight loss or gain of >5% within 30 days of Screening, as reported by subject.
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, metabolic urologic, dermatologic, renal, allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) and any other major 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 |
|---|---|---|
| PF-062526161.0 milligram per kilogram of PF-06252616, IV infusion, single dose | Biological | 1 |
| PlaceboPlacebo for PF-06252616, IV infusion, single dose | Drug | 1 |
| PF-062526163.0 milligram per kilogram of PF-06252616, IV infusion, single dose | Biological | 2 |
| PlaceboPlacebo for PF-06252616, IV infusion, single dose | Drug | 2 |
| PF-0625216110.0 milligram per kilogram of PF-06252616, IV infusion, single dose | Biological | 3 |
| PlaceboPlacebo for PF-06252616, IV infusion, single dose | Drug | 3 |
| PF-062526163.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose | Biological | 4 |
| PlaceboPlacebo for PF-06252616, Subcutaneous injection, single dose | Drug | 4 |
| PF-0625261610.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose | Biological | 5 |
| PlaceboPlacebo for PF-06252616, IV infusion, repeat dose | Drug | 5 |
| PF-0625261620.0 milligram per kilogram of PF-06252616, IV infusion, single dose | Biological | 6 |
| PlaceboPlacebo for PF-06252616, IV infusion, single dose | Drug | 6 |
| PF-0625261640.0 milligram per kilogram of PF-06252616, IV infusion, single dose | Biological | 7 |
| PlaceboPlacebo for PF-06252616, IV infusion, single dose | Drug | 7 |
Primary outcome
Incidence of treatment related Adverse Events.
Time frame: Day 197
Severity of treatment related Adverse Events.
Time frame: Day 197
Incidence of abnormal lab findings.
Time frame: Day 197
Magnitude of abnormal lab findings.
Time frame: Day 197
Abnormal and clinically relevant changes in Blood Pressure.
Time frame: Day 197
Abnormal and clinically relevant changes in Pulse Rate.
Time frame: Day 197
Abnormal and clinically relevant changes in Respiratory Rate.
Time frame: Day 197
Abnormal and clinically relevant changes in temperature.
Time frame: Day 197
Abnormal and clinically relevant changes in ECG parameters.
Time frame: Day 197
16 secondary outcomes
PF-06252616 concentration in serum as measured by a validated PK assay for Cmax (maximum concentration)
Time frame: Through Day 197 post dosing
Pharmacodynamic activity as measured by serum concentrations of GDF-8 (myostatin) as measured by a GDF-8 assay
Time frame: Through Day 197 post dosing
Incidence of development of anti-drug antibody (ADA) as measured by an ADA assay
Time frame: Through Day 197 post dosing
Pharmacologic activity as measured by the percent change in lean body mass as measured by DXA
Time frame: Through Day 113 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Tmax (time to reach maximum concentration)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUCinf (area under the curve serum concentration-time profile from time zero to infinity
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUClast (area under the curve serum concentration from time zero to the time of the last quantifiable concentration)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for t1/2 (half-life time for the serum concentration to decrease by half).
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for AUCτ (area under the curve serum concentration by dose interval)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for MRT (mean residence time)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CL (rate of clearance from serum)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for CLss (rate of steady state clearance from serum in the repeat dose cohort)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Vz /F(volume of distribution is the theoretical volume which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for Vss(volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired concentration of a drug.
Time frame: Through Day 197 post dosing
Steady state volume of distribution is the apparent volume of distribution at steady-state.)
Time frame: Through Day 197 post dosing
PF-06252616 concentration in serum as measured by a validated PK assay for RAC (accumulation ratio for AUC)
Time frame: Through Day 197 post dosing
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 25 Sep 2014.
- Derived from this study: PubMed 36104012Wojciechowski J, Purohit VS, Harnisch LO, Dua P, Tan B, Nicholas T. Population PK and PD Analysis of Domagrozumab in Pediatric Patients with Duchenne Muscular Dystrophy. Clin Pharmacol Ther. 2022 Dec;112(6):1291-1302. doi: 10.1002/cpt.2747. Epub 2022 Oct 4.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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 PF-06252616 and PF-06252161 in people with Healthy, run by 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 2 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 25 Sep 2014. 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?
Incidence of treatment related Adverse Events. (time frame: Day 197). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01616277, which also lists 1 linked publication.
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 25 Sep 2014.