Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03423446 | Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment | PHASE1 | COMPLETED | 16 | — | — | Nov 28, 2017 | Jun 15, 2018 | Oct 15, 2018 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| Severe Hepatic Impairment | EXPERIMENTAL | Up to 8 subjects with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15 points) |
| Healthy Control | EXPERIMENTAL | Up to 8 healthy control subjects with normal hepatic function |
| Name | Type | Description |
|---|---|---|
| Telotristat Ethyl | DRUG | Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose |
Inclusion Criteria: * Adult male and female subjects ≥18 to ≤70 years of age, inclusive, at the time of Screening: 1. Females of non-childbearing potential are to be surgically sterile (documented hysterectomy, tubal ligation, or bilateral salpingo-oophorectomy) or postmenopausal (defined as at ...