Healthy SubjectsPhase 1NCT03230383

A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects

A Phase 1 study testing PF-06865571 in people with Healthy Subjects, run by Pfizer at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
What is being tested?: PF-06865571
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 2 sitesin 2 countries
Study dates: 1 Aug 2017to 3 May 2018
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
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy males and female of non-childbearing potential;
Age of 18-55, inclusive;
Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
Body weight greater than 50 kg;
Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Who cannot join

Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
Subjects with fasting LDL-C level >190 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
Subjects with fasting TG level >400 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug test.
History of regular alcohol consumption exceeding 7 drinks/week for female subjects or 14 drinks/week for male subjects (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months before screening.

Show all 11Show fewer

Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of investigational product (whichever is longer).
Use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day or 2 chews of tobacco per day.
Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
Unwilling or unable to comply with the criteria in the Lifestyle Requirements section of this protocol.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Pfizer New Haven Clinical Research Unit
New Haven, Connecticut, 06511

Other trials in United States

Belgium1 site

Pfizer Clinical Research Unit
Brussels, B-1070

Other trials in Belgium

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects

This will be an investigator- and subject-blinded (sponsor open), randomized, placebo controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts), and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10 subjects dosed in each cohort.

For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.

Conditions: Healthy Subjects
Being tested: PF-06865571, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PF-06865571Drug
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
PF-06865571Drug
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
PF-06865571Drug
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
PF-06865571Drug
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
PF-06865571Drug
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
PF-06865571Drug
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
PF-06865571Drug
Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
PlaceboDrug
Matching Placebo for PF-06865571 for each cohort.

Study groups in NCT03230383
Study group	Role	What they receive
Cohort 1_90mg and Matching Placebo	Experimental	Not described Receives: Drug: PF-06865571; Drug: Placebo
Cohort 2_300mg and Matching Placebo	Experimental	Not described Receives: Drug: PF-06865571; Drug: Placebo
Cohort 3_900mg and Matching Placebo	Experimental	Not described Receives: Drug: PF-06865571; Drug: Placebo
Cohort 4_1800mg and Matching Placebo	Experimental	Not described Receives: Drug: PF-06865571; Drug: Placebo
Cohort 5_3000mg and Matching Placebo	Experimental	Not described Receives: Drug: PF-06865571; Drug: Placebo
Optional Cohort 6_TBD mg and Matching Placebo	Experimental	Not described Receives: Drug: PF-06865571; Drug: Placebo
Optional Cohort 7_TBD mg and Matching Placebo	Experimental	Not described Receives: Drug: PF-06865571; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of subjects with adverse events (AEs)
Number of participants with reported adverse events
Measured: Baseline up to 35 days after last dose of study medication
Number of subjects with laboratory tests findings of potential clinical importance
Number of participants with potentially clinically important laboratory test findings
Measured: Baseline (Day 0) up to 24 days after last dose of study medication
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Number of participants with potentially clinically important ECG findings
Measured: Baseline (Day 0) up to 24 days after last dose of study medication
Number of subjects with vital signs findings of potential clinical importance
Number of participants with potentially clinically important vital sign measurements
Measured: Baseline (Day 0) up to 24 days after last dose of study medication

Secondary outcomes (7)

Maximum Observed Plasma Concentration (Cmax) for PF-06865571
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
AUCtau for PF-06865571
Area under the concentration-time curve calculated by linear trapezoidal rule from time zero to the end of the dosing interval (i.e., 24 h) at steady state.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Time to Reach Maximum Observed Concentration for PF-06865571
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Dose normalized Cmax for PF-06865571
Following log-transformation, dose normalized Cmax will be analysed using a mixed model appropriate to the study design.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571
Sum of [urine concentration * sample volume] for each collection over the dosing interval
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571
100* Aetau/Dose
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Renal clearance (CLr) for PF-06865571
Aetau/AUCtau
Measured: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20173 May 2018

First posted26 Jul 2017
Study start1 Aug 2017
Primary completion3 May 2018
Study completion3 May 2018

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 Healthy SubjectsStudies 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: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03230383
Sponsor's protocol ID: C2541002
Other IDs: 2017-001649-28, 2017
Status last verified: May 2018
First submitted: 24 Jul 2017
Last updated: 23 May 2018
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical\_trials/trial\_data\_and\_results/data\_requests

Publications

Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.
PubMed 36690550

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 23 May 2018. 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 Assess The Safety, Tolerability, And Pharmacokinetics Of Multiple Escalating Oral Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
ClinicalTrials.gov ID: NCT03230383
Acronym / sponsor ID: C2541002
Conditions: Healthy Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 1 Aug 2017 (actual)
Primary completion: 3 May 2018 (actual)
Study completion: 3 May 2018 (actual)
First posted: 26 Jul 2017 (actual)
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.

For a given subject in any cohort, the total study duration from screening to follow-up phone call will be between approximately 7 to 11 weeks.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Cohort 1_90mg and Matching Placebo	Experimental	Drug: PF-06865571, Drug: Placebo
Cohort 2_300mg and Matching Placebo	Experimental	Drug: PF-06865571, Drug: Placebo
Cohort 3_900mg and Matching Placebo	Experimental	Drug: PF-06865571, Drug: Placebo
Cohort 4_1800mg and Matching Placebo	Experimental	Drug: PF-06865571, Drug: Placebo
Cohort 5_3000mg and Matching Placebo	Experimental	Drug: PF-06865571, Drug: Placebo
Optional Cohort 6_TBD mg and Matching Placebo	Experimental	Drug: PF-06865571, Drug: Placebo
Optional Cohort 7_TBD mg and Matching Placebo	Experimental	Drug: PF-06865571, Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Healthy males and female of non-childbearing potential;
Age of 18-55, inclusive;
Body Mass Index 22.5 to 35.4 kg/m2, inclusive;
Body weight greater than 50 kg;
Not on any prescription or non-prescription drugs within 7 days or 5 half-lives prior to first dose.

Key exclusion criteria (11 listed)

Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergises, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
Subjects with fasting LDL-C level >190 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
Subjects with fasting TG level >400 mg/dL following an overnight fast of at least 10 hours, at the Screening visit, confirmed by a single repeat, if deemed necessary.
Any condition possibly affecting drug absorption (eg, gastrectomy).
A positive urine drug test.

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-06865571Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.	Drug	Cohort 1_90mg and Matching Placebo
PF-06865571Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.	Drug	Cohort 2_300mg and Matching Placebo
PF-06865571Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.	Drug	Cohort 3_900mg and Matching Placebo
PF-06865571Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.	Drug	Cohort 4_1800mg and Matching Placebo
PF-06865571Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.	Drug	Cohort 5_3000mg and Matching Placebo
PF-06865571Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.	Drug	Optional Cohort 6_TBD mg and Matching Placebo
PF-06865571Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.	Drug	Optional Cohort 7_TBD mg and Matching Placebo
PlaceboMatching Placebo for PF-06865571 for each cohort.	Drug	Cohort 1_90mg and Matching Placebo, Cohort 2_300mg and Matching Placebo, Cohort 3_900mg and Matching Placebo, Cohort 4_1800mg and Matching Placebo, Cohort 5_3000mg and Matching Placebo, Optional Cohort 6_TBD mg and Matching Placebo, Optional Cohort 7_TBD mg and Matching Placebo

Primary outcome

Number of subjects with adverse events (AEs)
Time frame: Baseline up to 35 days after last dose of study medication
Number of participants with reported adverse events
Number of subjects with laboratory tests findings of potential clinical importance
Time frame: Baseline (Day 0) up to 24 days after last dose of study medication
Number of participants with potentially clinically important laboratory test findings
Number of subjects with electrocardiogram (ECG) findings of potential clinical importance
Time frame: Baseline (Day 0) up to 24 days after last dose of study medication
Number of participants with potentially clinically important ECG findings
Number of subjects with vital signs findings of potential clinical importance
Time frame: Baseline (Day 0) up to 24 days after last dose of study medication
Number of participants with potentially clinically important vital sign measurements

7 secondary outcomes

Maximum Observed Plasma Concentration (Cmax) for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
AUCtau for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Time to Reach Maximum Observed Concentration for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Dose normalized Cmax for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Days 1, 7, and 14
Amount of unchanged drug recovered in urine during the dosing interval (Aetau) for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Percent of dose recovered in urine as unchanged drug (Aetau %) for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14
Renal clearance (CLr) for PF-06865571
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 hour post dose on Day 14

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 23 May 2018.
Derived from this study: PubMed 36690550Amin NB, Saxena AR, Somayaji V, Dullea R. Inhibition of Diacylglycerol Acyltransferase 2 Versus Diacylglycerol Acyltransferase 1: Potential Therapeutic Implications of Pharmacology. Clin Ther. 2023 Jan;45(1):55-70. doi: 10.1016/j.clinthera.2022.12.008. Epub 2023 Jan 21.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests

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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

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06865571 in people with Healthy Subjects, run by Pfizer at 2 sites in 2 countries.

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 5 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 23 May 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Belgium. 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 subjects with adverse events (AEs) (time frame: Baseline up to 35 days after last dose of study medication). The study lists 4 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 NCT03230383, 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 23 May 2018.