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

NCT02411929 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2018-09-18

Study results available
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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.

Conditions

Interventions

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)

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-29
Primary Completion
2015-01-30
Completion
2015-02-09

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02411929 on ClinicalTrials.gov