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Study To Estimate The Relative Bioavailability of Ertugliflozin (PF-04971729, MK-8835) in Healthy Adult Participants (MK-8835-039)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01114568
First received: April 27, 2010
Last updated: March 16, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Healthy
Drug: Ertugliflozin 10 mg tablet
Drug: Ertugliflozin OC Fast
Drug: Ertugliflozin OC Slow
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • AUC from Hour 0 to infinity (AUCinf) for ertugliflozin [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ] [ Designated as safety issue: No ]
  • Maximum plasma concentration (Cmax) of ertugliflozin [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Ertugliflozin half life (t1/2) [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ] [ Designated as safety issue: No ]
  • Number of Participants Experiencing an Adverse Event (AE) [ Time Frame: Up to 28 days postdose (Up to 49 days) ] [ Designated as safety issue: Yes ]
  • Number of Participants Discontinuing Study Drug Due to an AE [ Time Frame: Up to Day 21 ] [ Designated as safety issue: Yes ]
  • Urinary glucose excretion [ Time Frame: Up to 48 hr. postdose (Up to Day 3 in each dosing period) ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
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.
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
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.
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
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.
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
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.
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
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.
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

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114568

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Pfizer
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01114568     History of Changes
Other Study ID Numbers: 8835-039 
Study First Received: April 27, 2010
Last Updated: March 16, 2016
Health Authority: Singapore: Singapore Health Sciences Authority (HSA)

Keywords provided by Merck Sharp & Dohme Corp.:
Relative Bioavailability
Pharmacokinetics
Pharmacodynamics

ClinicalTrials.gov processed this record on December 09, 2016