You are here

A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Omega Research Maitland, LLC
Orlando, Florida, 32810 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-Alcoholic Fatty Liver Disease (NAFLD)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male subjects or female subjects of non childbearing potential

- Total body weight of >50 kg (110 lbs) and a BMI greater than or equal to 25 kg/m2

- Medical diagnosis of Type 2 Diabetes Mellitus (T2DM) being treated with no more than 1
acceptable oral antidiabetic drug OR Subjects without a diagnosis of T2DM that meet 2
or more of the following 5 criteria commonly associated with metabolic syndrome

- Fasting Plasma Glucose (FPG) greater than or equal to 100 mg/dL;

- Documentation of at least stage 1 hypertension or medical history of
hypertension;

- Fasting serum HDL C pharmacological agents with explicit purpose to increase HDL-C;

- Fasting serum triglyceride (TG) greater than or equal to 150 mg/dL or on
pharmacological agents with explicit purpose to decrease TG;

- Waist circumference greater than or equal to 40 inches (102 cm) for males and 35
inches (89 cm) for females.

- Liver fat greater than or equal to 8% measured by MRI PDFF

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with acute or chronic medical or psychiatric condition.

- Subjects with any of the following clinical laboratory abnormalities:

- Fasting TG >400 mg/dL;

- AST, ALT, or GGT >2.0x ULN;

- Hemoglobin A1c (HbA1c) >7.0%;

- Fasting plasma glucose >270 mg/dL;

- Total bilirubin >1.5x ULN;

- Albumin

- Platelet count

- International normalized ratio (INR) greater than or equal to 1.3.

- A positive urine test for illicit drugs.

- History of regular alcohol consumption.

- Seated systolic BP>=160 mmHg and/or diastolic BP>=100 mmHg.

- Supine 12 lead ECG demonstrating a corrected QT (QTcF) interval >450 msec or a QRS
interval >120 msec.

- Subjects with an estimated GFR

- Evidence or diagnosis of other forms of chronic liver diseases.

- Subjects with any of the following medical conditions:

- Any condition possibly affecting drug absorption (eg prior bariatric surgery,
gastrectomy, ileal resection);

- Diagnosis of type 1 diabetes mellitus;

- History of congestive heart failure, unstable angina, myocardial infarction,
stroke, or transient ischemic attack;

- Any malignancy not considered cured (except basal cell carcinoma and squamous
cell carcinoma of the skin);

- Active placement of medical devices in/on thoracic or abdominal cavities such as
pacemakers, defibrillators;

- Subjects with any anatomical or pathological abnormality that would either preclude or
tend to confound the analysis of study data.

- Blood donation of approximately 1 pint or more within 60 days prior to dosing.

- Subjects taking prohibited concomitant medication(s) or those unwilling/unable to
switch to permitted concomitant medication(s)

- Weight loss of greater than or equal to 5% within 1 month prior to Screening.

- Unwilling or unable to comply with the Lifestyle Requirements criteria of the
protocol.

- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential; fertile male subjects who are unwilling or unable to use
highly effective method(s) of contraception.

- Investigator site staff members or Pfizer employees, including their family members,
directly involved in the conduct of the study.

- Subjects with known prior treatment with or participation in a clinical trial
involving any of the IPs

NCT03776175
Pfizer
Recruiting
A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE A Study To Assess Pharmacodynamics, Safety And Tolerability Of PF-05221304 And PF-06865571 Co-Administered For 6 Weeks In Adults With Non-Alcoholic Fatty Liver Disease.
Official Title  ICMJE A PHASE 2A, RANDOMIZED, DOUBLE BLIND (SPONSOR-OPEN), PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE PHARMACODYNAMICS, SAFETY AND TOLERABILITY OF PF-05221304 AND PF-06865571 CO-ADMINISTERED FOR 6 WEEKS IN ADULTS WITH NON-ALCOHOLIC FATTY LIVER DISEASE (NAFLD)
Brief SummaryThis study is to assess the effect of PF 05221304 alone, PF 06865571 alone, the co administration of PF 05221304 and PF 06865571, or placebo on whole liver fat in subjects with NAFLD. In addition, this study will evaluate the safety and tolerability of co administration of PF 05221304 and PF 06865571 along with the effects on selected pharmacodynamics (PD)/exploratory parameters, compared to administration of PF 05221304 alone, PF 06865571 alone, and placebo in adults with NAFLD.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Non-Alcoholic Fatty Liver Disease (NAFLD)
Intervention  ICMJE
  • Drug: PF-05221304 Monotherapy
    Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.
    Other Name: Arm B
  • Drug: PF-06865571 Monotherapy
    Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.
    Other Name: Arm C
  • Drug: Placebo
    Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
    Other Name: Arm A
  • Drug: PF-05221304 and PF-06865571 Combination
    Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.
    Other Name: Arm D
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo (PF 05221304) BID Placebo (PF 06865571) BID
    Intervention: Drug: Placebo
  • Experimental: PF-05221304 Monotherapy
    15 mg PF-05221304 BID Placebo (PF-06865571) BID
    Interventions:
    • Drug: PF-05221304 Monotherapy
    • Drug: Placebo
  • Experimental: PF-06865571 Monotherapy
    Placebo (PF-05221304) BID 300 mg PF-06865571 BID
    Interventions:
    • Drug: PF-06865571 Monotherapy
    • Drug: Placebo
  • Experimental: PF-05221304 and PF-06865571 Combination
    15 mg PF-05221304 BID 300 mg PF-06865571 BID
    Interventions:
    • Drug: PF-05221304 Monotherapy
    • Drug: PF-06865571 Monotherapy
    • Drug: PF-05221304 and PF-06865571 Combination
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 12, 2018)
98
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 14, 2019
Actual Primary Completion DateSeptember 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male subjects or female subjects of non childbearing potential
  • Total body weight of >50 kg (110 lbs) and a BMI greater than or equal to 25 kg/m2
  • Medical diagnosis of Type 2 Diabetes Mellitus (T2DM) being treated with no more than 1 acceptable oral antidiabetic drug OR Subjects without a diagnosis of T2DM that meet 2 or more of the following 5 criteria commonly associated with metabolic syndrome

    • Fasting Plasma Glucose (FPG) greater than or equal to 100 mg/dL;
    • Documentation of at least stage 1 hypertension or medical history of hypertension;
    • Fasting serum HDL C <40 mg/dL for males and <50 mg/dL for females, or on pharmacological agents with explicit purpose to increase HDL-C;
    • Fasting serum triglyceride (TG) greater than or equal to 150 mg/dL or on pharmacological agents with explicit purpose to decrease TG;
    • Waist circumference greater than or equal to 40 inches (102 cm) for males and 35 inches (89 cm) for females.
  • Liver fat greater than or equal to 8% measured by MRI PDFF

Exclusion Criteria:

  • Subjects with acute or chronic medical or psychiatric condition.
  • Subjects with any of the following clinical laboratory abnormalities:

    • Fasting TG >400 mg/dL;
    • AST, ALT, or GGT >2.0x ULN;
    • Hemoglobin A1c (HbA1c) >7.0%;
    • Fasting plasma glucose >270 mg/dL;
    • Total bilirubin >1.5x ULN;
    • Albumin < lower limit of normal (LLN);
    • Platelet count <0.95x LLN;
    • International normalized ratio (INR) greater than or equal to 1.3.
  • A positive urine test for illicit drugs.
  • History of regular alcohol consumption.
  • Seated systolic BP>=160 mmHg and/or diastolic BP>=100 mmHg.
  • Supine 12 lead ECG demonstrating a corrected QT (QTcF) interval >450 msec or a QRS interval >120 msec.
  • Subjects with an estimated GFR <60 mL/min/1.73m2.
  • Evidence or diagnosis of other forms of chronic liver diseases.
  • Subjects with any of the following medical conditions:

    • Any condition possibly affecting drug absorption (eg prior bariatric surgery, gastrectomy, ileal resection);
    • Diagnosis of type 1 diabetes mellitus;
    • History of congestive heart failure, unstable angina, myocardial infarction, stroke, or transient ischemic attack;
    • Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin);
    • Active placement of medical devices in/on thoracic or abdominal cavities such as pacemakers, defibrillators;
  • Subjects with any anatomical or pathological abnormality that would either preclude or tend to confound the analysis of study data.
  • Blood donation of approximately 1 pint or more within 60 days prior to dosing.
  • Subjects taking prohibited concomitant medication(s) or those unwilling/unable to switch to permitted concomitant medication(s)
  • Weight loss of greater than or equal to 5% within 1 month prior to Screening.
  • Unwilling or unable to comply with the Lifestyle Requirements criteria of the protocol.
  • Pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential; fertile male subjects who are unwilling or unable to use highly effective method(s) of contraception.
  • Investigator site staff members or Pfizer employees, including their family members, directly involved in the conduct of the study.
  • Subjects with known prior treatment with or participation in a clinical trial involving any of the IPs
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03776175
Other Study ID Numbers  ICMJE C3711001
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now