HealthyPhase 1NCT02070939
Study To Evaluate Safety And Tolerability Of Single And Multiple Ascending Doses Of PF- 06260414 In Healthy Western And Japanese Male Subjects
A Phase 1 study testing PF-06260414 in people with Healthy, run by Pfizer at 1 site in United States.
Trial summary
This single and multiple ascending dose study is the first evaluation of PF-0626414, a Selective Androgen Receptor Modulator in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male subjects . Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PF-06260414
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2015
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male between the ages of 21 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Additional inclusion criteria for subjects to be enrolled in Japanese cohort only: Japanese subjects who have four Japanese grandparents born in Japan.
Who cannot join
- Serum total testosterone level <270 or >1070 ng/dL
- Serum Prostate Specific Antigen (PSA) level >4 ng/mL.
- Hematocrit >48%.
- eGFR >150 ml/min/1.73m2.
Trial locations and contacts
1 site in 1 country.
United States1 site
New Haven Clinical Research Unit
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06260414 In Healthy Western And Japanese Male Subjects
This single and multiple ascending dose study is the first evaluation of PF-0626414, a Selective Androgen Receptor Modulator in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male subjects .
- Conditions
- Healthy
- Being tested
- PF-06260414, Placebo
- Keywords
- Phase 1, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Dose Escalation, Safety Tolerability, PK, PD, PF-06460414
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-06260414Drug
Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format
PlaceboDrug
Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format
PF-06260414Drug
Subjects will receive PF-06260414 doses (solution) twice daily for 14 days
PlaceboDrug
Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days
PF-06260414Drug
Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days
PlaceboDrug
Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days
| Study group | Role | What they receive |
|---|---|---|
| SAD cohorts 1-7 Experimental Arm | Experimental | Not described Receives: Drug: PF-06260414 |
| SAD Cohorts 1-7 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| MAD cohorts 2-6 Experimental Arm | Experimental | Not described Receives: Drug: PF-06260414 |
| MAD cohorts 2-6 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
| Japanese MAD cohort 7 Experimental arm | Experimental | Not described Receives: Drug: PF-06260414 |
| Japanese MAD cohort 7 Placebo Arm | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate)
Measured: 6 weeks
Changes from baseline in 12-lead ECG parameters
Quantitative changes in ECG intervals
Measured: 6 weeks
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
Measured: 6 weeks
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis
Measured: 6 weeks
24 hour creatinine clearance (baseline and day 14).
Measured: Baseline, Day 14
Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG.
Measured: 6 weeks
Changes from baseline in Prostate Specific Antigen (PSA).
Measured: 6 weeks
Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.
Measured: 6 weeks
Secondary outcomes (5)
Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½.
Measured: 6 weeks
Multiple Dose: Cmax, Tmax Ctrough, C,av,AUC,CL/F, Vz/F, Rac , Rac,Cmax , PTR, Cmax(dn),AUCτ(dn), t½.
Measured: 6 weeks
Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr).
Measured: 6 weeks
Single Dose: AUC(hormone or PSA), C0(hormone or PSA), Maximum PCB, Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).
The effects of PF- 06260414 on sex hormones (total testosterone, free testosterone, estradiol, SHBG, LH and FSH) will be evaluated according to the scheduled timepoints in single ascending dose study
Measured: 6 weeks
Multiple Dose: AUC(hormone or PSA), C0(hormone or PSA), Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2015
- Study completionMar 2015
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
- 72 participants (actual)
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
- NCT02070939
- Sponsor's protocol ID
- B7411001
- Status last verified
- Nov 2018
- First submitted
- 22 Feb 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bhattacharya I, Tarabar S, Liang Y, Pradhan V, Owens J, Oemar B. Safety, Pharmacokinetic, and Pharmacodynamic Evaluation After Single and Multiple Ascending Doses of a Novel Selective Androgen Receptor Modulator in Healthy Subjects. Clin Ther. 2016 Jun;38(6):1401-1416. doi: 10.1016/j.clinthera.2016.03.025. Epub 2016 Apr 13.
PubMed 27085586
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double Blind (Sponsor Open), Placebo Controlled, Single- And Multiple Dose Escalation, Parallel Group Study To Evaluate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Pf-06260414 In Healthy Western And Japanese Male Subjects
- ClinicalTrials.gov ID
- NCT02070939
- Acronym / sponsor ID
- B7411001
- Conditions
- Healthy
- Keywords
- Phase 1, Randomized, Double Blind, Placebo-Controlled, Single and Multiple Dose Escalation, Safety Tolerability, PK, PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 25 Feb 2014 (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 single and multiple ascending dose study is the first evaluation of PF-0626414, a Selective Androgen Receptor Modulator in humans. The goal is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics in healthy western and Japanese male subjects .
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SAD cohorts 1-7 Experimental Arm | Experimental | Drug: PF-06260414 |
| SAD Cohorts 1-7 Placebo Arm | Placebo comparator | Drug: Placebo |
| MAD cohorts 2-6 Experimental Arm | Experimental | Drug: PF-06260414 |
| MAD cohorts 2-6 Placebo Arm | Placebo comparator | Drug: Placebo |
| Japanese MAD cohort 7 Experimental arm | Experimental | Drug: PF-06260414 |
| Japanese MAD cohort 7 Placebo Arm | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male between the ages of 21 and 50 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
- Additional inclusion criteria for subjects to be enrolled in Japanese cohort only: Japanese subjects who have four Japanese grandparents born in Japan.
Key exclusion criteria (4 listed)
- Serum total testosterone level <270 or >1070 ng/dL
- Serum Prostate Specific Antigen (PSA) level >4 ng/mL.
- Hematocrit >48%.
- eGFR >150 ml/min/1.73m2.
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-06260414Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format | Drug | SAD cohorts 1-7 Experimental Arm |
| PlaceboSubjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format | Drug | SAD Cohorts 1-7 Placebo Arm |
| PF-06260414Subjects will receive PF-06260414 doses (solution) twice daily for 14 days | Drug | MAD cohorts 2-6 Experimental Arm |
| PlaceboSubjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days | Drug | MAD cohorts 2-6 Placebo Arm |
| PF-06260414Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days | Drug | Japanese MAD cohort 7 Experimental arm |
| PlaceboJapanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days | Drug | Japanese MAD cohort 7 Placebo Arm |
Primary outcome
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate)
Time frame: 6 weeks
Changes from baseline in 12-lead ECG parameters
Time frame: 6 weeks
Quantitative changes in ECG intervals
Incidence and severity of treatment emergent adverse events and withdrawals due to treatment emergent adverse events
Time frame: 6 weeks
Incidence and magnitude of treatment emergent clinical laboratory abnormalities including hematology (including total Hb and hematocrit), chemistry, fasting glucose, urinalysis
Time frame: 6 weeks
24 hour creatinine clearance (baseline and day 14).
Time frame: Baseline, Day 14
Changes from baseline in total testosterone, free testosterone, estradiol, LH, FSH, SHBG.
Time frame: 6 weeks
Changes from baseline in Prostate Specific Antigen (PSA).
Time frame: 6 weeks
Changes from baseline in total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides.
Time frame: 6 weeks
5 secondary outcomes
Single Dose: Cmax, Tmax, AUClast, AUCinf, CL/F, Vz/F, and t½,Cmax(dn), AUCinf(dn), AUClast(dn), t½.
Time frame: 6 weeks
Multiple Dose: Cmax, Tmax Ctrough, C,av,AUC,CL/F, Vz/F, Rac , Rac,Cmax , PTR, Cmax(dn),AUCτ(dn), t½.
Time frame: 6 weeks
Urinary Pharmacokinetics: Amount of PF 06260414 excreted unchanged (AE and AE%), renal clearance (CLr).
Time frame: 6 weeks
Single Dose: AUC(hormone or PSA), C0(hormone or PSA), Maximum PCB, Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).
Time frame: 6 weeks
Multiple Dose: AUC(hormone or PSA), C0(hormone or PSA), Cmax(hormone or PSA), Cmin(hormone or PSA), Tmax(hormone or PSA), Tmin(hormone or PSA).
Time frame: 6 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 14 Nov 2018.
- Derived from this study: PubMed 27085586Bhattacharya I, Tarabar S, Liang Y, Pradhan V, Owens J, Oemar B. Safety, Pharmacokinetic, and Pharmacodynamic Evaluation After Single and Multiple Ascending Doses of a Novel Selective Androgen Receptor Modulator in Healthy Subjects. Clin Ther. 2016 Jun;38(6):1401-1416. doi: 10.1016/j.clinthera.2016.03.025. Epub 2016 Apr 13.
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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-06260414 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 3 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 14 Nov 2018. 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?
Changes from baseline vital signs (blood pressure, pulse rate, oral temperature and respiration rate) (time frame: 6 weeks). The study lists 8 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 NCT02070939, 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 14 Nov 2018.