Phase 1 Single- and Multiple-Ascending-Dose Randomized Studies of the Safety, Pharmacokinetics, and Pharmacodynamics of AG-348, a First-in-Class Allosteric Activator of Pyruvate Kinase R, in Healthy Volunteers

Clinical Pharmacology in Drug Development

Volumn 8, Issue 2, 2019, Pages 246-259

  Yang, Hua ^a   Merica, Elizabeth ^a   Chen, Yue ^a   Cohen, Marvin ^b   Goldwater, Ronald ^c   Kosinski, Penelope A ^a   Kung, Charles ^a   Silver, Bruce A ^d  

^a Jason)   (United States)

^b MBC Pharma Solutions   (United States)

^c PAREXEL INTERNATIONAL   (United States)

^d Bruce A Silver Clinical Science and Development   (United States)

Author keywords

experimental therapies; pharmacokinetics pharmacodynamics; pyruvate kinase deficiency; randomized clinical trial; red blood cell metabolism

Indexed keywords

DRUG METABOLITE; MITAPIVAT; PLACEBO; PYRUVATE KINASE; PIPERAZINE DERIVATIVE; QUINOLINE DERIVATIVE;

ABDOMINAL DISCOMFORT; ADULT; AREA UNDER THE CURVE; ARTICLE; COHORT ANALYSIS; CONTROLLED STUDY; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG ERUPTION; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FEMALE; GLYCOLYSIS; HEADACHE; HUMAN; HUMAN EXPERIMENT; HYPERHIDROSIS; LOSS OF APPETITE; MALE; MAXIMUM CONCENTRATION; NAUSEA; NAUSEA AND VOMITING; NORMAL HUMAN; PHARMACODYNAMICS; PHASE 1 CLINICAL TRIAL; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTLESSNESS; SIDE EFFECT; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; CLINICAL TRIAL; DRUG ADMINISTRATION; MIDDLE AGED;

ADULT; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLYCOLYSIS; HEALTHY VOLUNTEERS; HUMANS; MALE; MIDDLE AGED; PIPERAZINES; QUINOLINES;

EID: 85052624044     PISSN: 2160763X     EISSN: 21607648     Source Type: Journal    
DOI: 10.1002/cpdd.604     Document Type: Article

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