A Phase 1, Randomized, Placebo- and Active-Controlled Crossover Study to Determine the Effect of Single-Dose Ertugliflozin on QTc Interval in Healthy Volunteers

Clinical Pharmacology in Drug Development

Volumn 7, Issue 5, 2018, Pages 513-523

  Sahasrabudhe, Vaishali ^a   Saur, Didier ^a   Matschke, Kyle ^a   Terra, Steven G ^a   Hickman, Anne ^a   Huyghe, Isabelle ^a   Shi, Haihong ^a   Cutler, David L ^b  

^a PFIZER INC   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

cardiovascular; diabetes; ertugliflozin; QTc interval; safety

Indexed keywords

ERTUGLIFLOZIN; MOXIFLOXACIN; PLACEBO; 5-(4-CHLORO-3-(4-ETHOXYBENZYL)PHENYL)-1-HYDROXYMETHYL-6,8-DIOXABICYCLO(3.2.1)OCTANE-2,3,4-TRIOL; FUSED HETEROCYCLIC RINGS;

ADULT; AREA UNDER THE CURVE; ARTICLE; CONTROLLED STUDY; CROSSOVER PROCEDURE; DIARRHEA; DISEASE SEVERITY; DRUG BLOOD LEVEL; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; ELECTROCARDIOGRAPHY; FEMALE; HEADACHE; HEART RATE; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM CONCENTRATION; NAUSEA; NORMAL HUMAN; PHASE 1 CLINICAL TRIAL; POSITIONAL DIZZINESS; PRIORITY JOURNAL; PROSPECTIVE STUDY; QTC INTERVAL; RANDOMIZED CONTROLLED TRIAL; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; ADMINISTRATION AND DOSAGE; ADVERSE EVENT; CLINICAL TRIAL; COMPARATIVE STUDY; DRUG EFFECT; MIDDLE AGED; PHARMACOLOGY; SAMPLE SIZE; YOUNG ADULT;

ADULT; BRIDGED BICYCLO COMPOUNDS, HETEROCYCLIC; CROSS-OVER STUDIES; ELECTROCARDIOGRAPHY; FEMALE; HEALTHY VOLUNTEERS; HEART RATE; HUMANS; MALE; MIDDLE AGED; MOXIFLOXACIN; SAMPLE SIZE; SODIUM-GLUCOSE TRANSPORTER 2 INHIBITORS; YOUNG ADULT;

EID: 85044246393     PISSN: 2160763X     EISSN: 21607648     Source Type: Journal    
DOI: 10.1002/cpdd.421     Document Type: Article

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