A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)

NCT02411929

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Type 2 Diabetes Mellitus
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects between the ages of 18 and 65 years.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs.)

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


- 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).


- Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).


- A positive urine drug screen for drugs of abuse or recreational drugs.


- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or
human immunodeficiency virus (HIV) results.


- History of abuse of alcohol or binge drinking and/or any other illicit drug use or
dependence within 6 months of Screening.


- Current smokers and those who have smoked any substance within the last 12 months.


- Treatment with an investigational drug within 1 month preceding the first dose of
study medication.


- Have participated in any clinical study with exposure to 14^C in the last 12 months.


- Any radiation exposure, including that which is projected to result from the present
study, excluding background radiation but including diagnostic x-rays and other
medical exposures. No occupationally exposed worker, as defined in the Ionising
Radiation Regulation 1999, shall participate in the study.


- Use of prescription or nonprescription drugs (including vitamins and dietary
supplements) within 7 days prior to the first dose of study medication.


- Use of herbal supplements within 28 days prior to the first dose of study medication.


- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 56 days prior to dosing.


- Participants who have previously participated in a clinical trial for ertugliflozin.


- Serious adverse reaction or serious hypersensitivity to any drug or the formulation
excipients.

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 1 Study of Ertugliflozin in Healthy Male Participants (MK-8835-020)
Official Title  ICMJE A Phase 1, Open-Label, Non-Randomized, 2-Period, Fixed Sequence, Study to Assess the Absolute Bioavailability and Fraction Absorbed of Ertugliflozin in Health Male Subjects Using a 14^C-Microdose Approach
Brief Summary This study will evaluate the absolute oral bioavailability (F) and fraction absorbed (Fa) of ertugliflozin following oral administration of unlabeled ertugliflozin (MK-8835) and intravenous (IV) and oral administration of 14^C-labeled ertugliflozin in healthy male participants.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Unlabeled ertugliflozin for oral use
    15 mg oral (3 x 5 mg tablets)
  • Drug: 14^C-labeled ertugliflozin for IV use
    100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin)
  • Drug: 14^C-labeled ertugliflozin for oral use
    100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin)
Study Arms  ICMJE Experimental: Ertugliflozin
Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. ? Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
Interventions:
  • Drug: Unlabeled ertugliflozin for oral use
  • Drug: 14^C-labeled ertugliflozin for IV use
  • Drug: 14^C-labeled ertugliflozin for oral use
Publications * Raje S, Callegari E, Sahasrabudhe V, Vaz A, Shi H, Fluhler E, Woolf EJ, Schildknegt K, Matschke K, Alvey C, Zhou S, Papadopoulos D, Fountaine R, Saur D, Terra SG, Stevens L, Gaunt D, Cutler DL. Novel Application of the Two-Period Microtracer Approach to Determine Absolute Oral Bioavailability and Fraction Absorbed of Ertugliflozin. Clin Transl Sci. 2018 Jul;11(4):405-411. doi: 10.1111/cts.12549. Epub 2018 Mar 25.

*   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 3, 2015)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 9, 2015
Actual Primary Completion Date January 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects between the ages of 18 and 65 years.
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m^2; and a total body weight >50 kg (110 lbs.)

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).
  • Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
  • A positive urine drug screen for drugs of abuse or recreational drugs.
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results.
  • History of abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening.
  • Current smokers and those who have smoked any substance within the last 12 months.
  • Treatment with an investigational drug within 1 month preceding the first dose of study medication.
  • Have participated in any clinical study with exposure to 14^C in the last 12 months.
  • Any radiation exposure, including that which is projected to result from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures. No occupationally exposed worker, as defined in the Ionising Radiation Regulation 1999, shall participate in the study.
  • Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days prior to the first dose of study medication.
  • Use of herbal supplements within 28 days prior to the first dose of study medication.
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
  • Participants who have previously participated in a clinical trial for ertugliflozin.
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 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  
 
Administrative Information
NCT Number  ICMJE NCT02411929
Other Study ID Numbers  ICMJE 8835-020
B1521043 ( Other Identifier: Pfizer Protocol Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialD…
URL:http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Medical DirectorMerck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date August 2018

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