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Healthy VolunteersPhase 1NCT02855177

A Multiple Dose Safety And Pharmacokinetic (PK) Study Of PF-06427878 In Overweight-Obese, Otherwise Healthy Subjects

A Phase 1 study testing PF-06427878 in people with Healthy Volunteers, run by Pfizer at 2 sites in United States.

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

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PF-06427878
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
2 sitesUnited States
Study dates
24 Aug 2016to 12 Apr 2017
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 male and/or female subjects of non childbearing potential.
  • Body Mass Index (BMI) of >=25 kg/m2; and a total body weight >50 kg
  • Subjects with liver fat >=6% and <=20%

Who cannot join

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • California Clinical Trials Medical Group

    Glendale, California, 91206

  • Qps-Mra, Llc

    South Miami, Florida, 33143

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Parallel-group Study To Assess The Safety, Tolerability, And Pharmacokinetics With 2-weeks Of Dosing Of Pf-06427878 In Overweight-obese, Otherwise Healthy Adult Subjects

PF-06427878 is a new compound proposed for the treatment of hyperlipidemia. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics after 2 weeks of dosing of PF-06427878 in overweight-obese, otherwise healthy adult subjects.

Being tested
Placebo, PF-06427878
Keywords
Hyperlipidemia
Medical subject headings
Hyperlipidemias

What participants receive

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

  • PlaceboDrug

    Placebo as suspension administered every 8 hours, with food

  • PF-06427878Drug

    500 mg suspension administered every 8 hours, with food

Study groups in NCT02855177
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
Receives: Drug: Placebo
PF-06427878ExperimentalPF-06427878 will be administered as an extemporaneously prepared suspension every 8 hours for 14 days
Receives: Drug: PF-06427878

What is being measured

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

  1. Number of Treatment Emergent Treatment-Related Adverse Events (AEs)

    Measured: Day -2 to Day 44

  2. Change from baseline in clinical laboratory tests

    Measured: Day 1 to Day 22

  3. Change from baseline in vital signs

    Measured: Day 0 to Day 22

  4. Change from baseline in cardiac conduction intervals assessed via 12-lead electrocardiogram

    Measured: Day 0 to Day 22

Secondary outcomes (16)

  1. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 1

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  2. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 1

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  3. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 1

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  4. Maximum Observed Plasma Concentration (Cmax) for PF-06427878 on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  5. Time to Reach Maximum Observed Plasma Concentration (Tmax) for PF-06427878 on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  6. Area Under the Curve for PF-06427878 during the dosing interval (AUCtau) on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  7. Plasma Decay Half-Life (t1/2) for PF-06427878 on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  8. Apparent Volume of Distribution (Vz/F) of PF-06427878 on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  9. Apparent Oral Clearance (CL/F) of PF-06427878 on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  10. Minimum Observed Plasma Concentration (Cmin) for PF-06427878 on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  11. Peak:Trough ratio of PF-06427878 on day 14

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  12. Accumulation ratio for Area Under the Curve during the dosing interval (Rac(AUCtau)) for PF-06427878 on day 14 relative to day 1

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  13. Accumulation ratio for Maximum Observed Plasma Concentration (Rac(Cmax)) for PF-06427878 on day 14 relative to day 1

    Measured: 0, 0.5, 1, 2, 3, 4, 6, 8 hours post dose

  14. Amount of PF-06427878 excreted in urine (Ae) on day 14

    Measured: 0-8 hours post dose

  15. Percent of dose excreted in urine as PF-06427878 (Ae%) on day 14

    Measured: 0-8 hours post dose

  16. Renal clearance of PF-06427878 (CLr) on day 14

    Measured: 0-8 hours post dose

Timeline

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

  1. First posted4 Aug 2016 (estimated)
  2. Study start24 Aug 2016
  3. Primary completion12 Apr 2017
  4. Study completion12 Apr 2017

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02855177
Sponsor's protocol ID
B7871005
Status last verified
May 2017
First submitted
1 Aug 2016
Last updated
4 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • Amin NB, Carvajal-Gonzalez S, Purkal J, Zhu T, Crowley C, Perez S, Chidsey K, Kim AM, Goodwin B. Targeting diacylglycerol acyltransferase 2 for the treatment of nonalcoholic steatohepatitis. Sci Transl Med. 2019 Nov 27;11(520):eaav9701. doi: 10.1126/scitranslmed.aav9701.

    PubMed 31776293

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-06427878 in people with Healthy Volunteers, run by Pfizer at 2 sites 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 1 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 May 2017. 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. 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?

Number of Treatment Emergent Treatment-Related Adverse Events (AEs) (time frame: Day -2 to Day 44). 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 NCT02855177, 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 4 May 2017.

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