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Trial record 1 of 1 for:    NCT01114568
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Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)

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ClinicalTrials.gov Identifier: NCT01114568
Recruitment Status : Completed
First Posted : May 3, 2010
Last Update Posted : March 17, 2016
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE April 27, 2010
First Posted Date  ICMJE May 3, 2010
Last Update Posted Date March 17, 2016
Study Start Date  ICMJE May 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2015)
  • Area under the plasma concentration-time curve (AUC) from time 0 to time of the last quantifiable concentration (AUClast) for ertugliflozin [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ]
  • AUC from Hour 0 to infinity (AUCinf) for ertugliflozin [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ]
  • Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ]
  • Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ]
  • Ertugliflozin half life (t1/2) [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ]
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 28 days postdose (Up to 49 days) ]
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 21 ]
  • Urinary glucose excretion [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2010)
  • Pharmacokinetic Endpoints: Cmax, Tmax, AUClast, AUCinf, and half life [ Time Frame: 1 week (i.e. 3 x 48 hours) ]
  • Safety Endpoints: assessed by physical examinations, adverse event monitoring, fluid balance, 12 lead ECGs, vital sign, and clinical laboratory measurements [ Time Frame: 1 month (actually 3 x 1 week + 2 days) ]
  • Pharmacodynamic Endpoints: Time course of the urinary glucose excretion over the intervals of 0 4 hour, 4 8 hour, 8 12 hour, 12 24 hour, 24 36 hour and 36 48 hour postdose. [ Time Frame: 1 week (i.e. 3 x 48 hours) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)
Official Title  ICMJE A Phase 1, Cross-Over, Single-Dose, Open-Label Study To Estimate The Relative Bioavailability Of Three Different Formulations Of PF-04971729 in Lean To Obese, Otherwise Healthy Adult Subjects
Brief Summary The purpose of this study is to examine the rate and extent of absorption of three oral formulations of ertugliflozin (PF 04971729, MK-8835) administered in lean to obese healthy volunteers.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Ertugliflozin 10 mg tablet
    A single dose of 10 mg ertugliflozin administered as 2x5 mg material sparing formulation tablets.
  • Drug: Ertugliflozin OC Fast
    Formulation B) Ertugliflozin 10 mg OC Fast
  • Drug: Ertugliflozin OC Slow
    Formulation C) Ertugliflozin 10 mg OC Slow
Study Arms  ICMJE
  • Experimental: Ertugliflozin 10 mg: tablet→osmotic capsule (OC) fast→OC slow
    The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 6 hours (EP-Osmotic Capsule-Fast) and C) a single dose of 10 mg extemporaneously prepared osmotic capsule with target release rate of approximately 14 hours (EP-Osmotic Capsule-Slow). Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
    Interventions:
    • Drug: Ertugliflozin 10 mg tablet
    • Drug: Ertugliflozin OC Fast
    • Drug: Ertugliflozin OC Slow
  • Experimental: Ertugliflozin 10 mg: tablet→OC slow→OC fast
    The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
    Interventions:
    • Drug: Ertugliflozin 10 mg tablet
    • Drug: Ertugliflozin OC Fast
    • Drug: Ertugliflozin OC Slow
  • Experimental: Ertugliflozin 10 mg: OC fast→tablet→OC slow
    The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
    Interventions:
    • Drug: Ertugliflozin 10 mg tablet
    • Drug: Ertugliflozin OC Fast
    • Drug: Ertugliflozin OC Slow
  • Experimental: Ertugliflozin 10 mg: OC fast→OC slow→tablet
    The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
    Interventions:
    • Drug: Ertugliflozin 10 mg tablet
    • Drug: Ertugliflozin OC Fast
    • Drug: Ertugliflozin OC Slow
  • Experimental: Ertugliflozin 10 mg: OC slow→tablet→OC fast
    The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
    Interventions:
    • Drug: Ertugliflozin 10 mg tablet
    • Drug: Ertugliflozin OC Fast
    • Drug: Ertugliflozin OC Slow
  • Experimental: Ertugliflozin 10 mg: OC slow→OC fast→tablet
    The three treatments are A) a single dose of 10 mg administered as 2x5 mg material sparing formulation tablets B) a single dose of 10 mg EP-Osmotic Capsule-Fast and C) a single dose of 10 mg EP-Osmotic Capsule-Slow. Treatment are administered on Day 1, Hour 0 of each dosing period with a minimum of 7-days wash-out between treatments A, B, and C.
    Interventions:
    • Drug: Ertugliflozin 10 mg tablet
    • Drug: Ertugliflozin OC Fast
    • Drug: Ertugliflozin OC Slow
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 Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2010)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 65 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). Women must be of non childbearing potential
  • Body Mass Index (BMI) of 18.5 to 35.4 kg/m2; and a total body weight >50 kg (110 lbs).
  • An informed consent document signed and dated by the subject.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • 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 screening).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen at Screening or prior to dosing in Period 1.
  • History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males (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 of screening.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries Singapore
 
Administrative Information
NCT Number  ICMJE NCT01114568
Other Study ID Numbers  ICMJE 8835-039
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP