Research Article

Pharmacokinetics, Safety, and Tolerability of Tenapanor in Healthy Chinese and Caucasian Volunteers: A Randomized, Open-Label, Single-Center, Placebo-Controlled Phase 1 Study

Table 4

Summary of adverse events.

Tenapanor 10 mg (n = 12)Tenapanor 30 mg (n = 12)Tenapanor 50 mg Chinese (n = 12)Tenapanor 50 mg caucasian (n = 11)Placebo (n = 12)

Participants experiencing at least 1 TEAE5 (41.7%)7 (58.3%)12 (100%)11 (100%)6 (50.0%)
AEs occurring in at least 2 participants in any group
 Diarrhea2 (16.7%)012 (100%)11 (100%)1 (8.3%)
 Increased systolic blood pressure1 (8.3%)3 (25.0%)01 (9.1%)0
 Hypertriglyceridemia1 (8.3%)2 (16.7%)001 (8.3%)
 Hyperlipidemia1 (8.3%)02 (16.7%)00
 Fever003 (25.0%)1 (8.3%)
 Abdominal distention0003 (27.3%)0
 Increased transaminases1 (8.3%)2 (16.7%)000
 Arrhythmia02 (16.7%)000

AE adverse event, TEAEtreatment-emergent adverse event.