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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03155893 | A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants | PHASE1 | COMPLETED | 59 | — | — | May 12, 2017 | Oct 27, 2017 | Nov 14, 2017 | 1 | United States |
Intersection-union test (IUT) analysis will be performed to evaluate the effect of AL-335 on QT/QTc interval changes after a single supratherapeutic dose of AL-335 on top of multiple doses of odalasvir (ODV) and simeprevir (SMV) versus placebo.
Exposure-response (ER) analysis will be performed to evaluate the effect of ODV on QT/QTc interval changes after multiple supratherapeutic doses of ODV.
ER analysis will be performed to evaluate the effect of ODV on QT/QTc interval changes after multiple supratherapeutic doses of ODV.
ER analysis will be performed to evaluate the effect of ODV on QT/QTc interval changes after multiple supratherapeutic doses of ODV.
ER analysis will be performed to evaluate the effect of ODV on PR interval changes after multiple supratherapeutic doses of ODV.
ER analysis will be performed to evaluate the effect of ODV on PR interval changes after multiple supratherapeutic doses of ODV.
ER analysis will be performed to evaluate the effect of ODV on PR interval changes after multiple supratherapeutic doses of ODV.
Echocardiogram measurements will be performed to evaluate the effect of multiple supratherapeutic doses of ODV on change in echocardiographic LVEF. The baseline for echocardiographic LVEF will be the average of Days -2 and -1.
Echocardiogram measurements will be performed to evaluate the effect of multiple supratherapeutic doses of ODV on change in echocardiographic LVEF. The baseline for echocardiographic LVEF will be the average of Days -2 and -1.
Echocardiogram measurements will be performed to evaluate the effect of multiple supratherapeutic doses of ODV on change in echocardiographic LVEF. The baseline for echocardiographic LVEF will be the average of Days -2 and -1.
| Arm | Type | Description |
|---|---|---|
| Panel 1: Treatment A | EXPERIMENTAL | Participants will receive odalasvir (ODV) placebo (matching 25 milligram \[mg\] ODV \[1\*25 mg tablet\]) and simeprevir (SMV) placebo (matching 150 mg SMV \[2\*75 mg capsules\]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram \[mg\] AL-335 \[3\*400 mg tablets\]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin \[1\*400 mg capsule\]) as a single dose on Day 1, 15 and 16 along with moxifloxacin 400 mg (1\*400 mg capsule) single dose on Day 2 orally under fed conditions. |
| Panel 1: Treatment B | EXPERIMENTAL | Participants will receive odalasvir (ODV) placebo (matching 25 milligram \[mg\] ODV \[1\*25 mg tablet\]) and simeprevir (SMV) placebo (matching 150 mg SMV \[2\*75 mg capsules\]) once daily from Day 1 to 16 along with single dose of AL-335 placebo (matching 1200 milligram \[mg\] AL-335 \[3\*400 mg tablets\]) on Day 15 and moxifloxacin placebo (matching 400 mg moxifloxacin \[1\*400 mg capsule\]) as a single dose on Day 1, 2 and 15 along with moxifloxacin 400 mg (1\*400 mg capsule) single dose on Day 16 orally under fed conditions. |
| Panel 1: Treatment C | EXPERIMENTAL | Participants will receive odalasvir (ODV) placebo (matching 25 milligram \[mg\] ODV \[1\*25 mg tablet\]) and simeprevir (SMV) placebo (matching 150 mg SMV \[2\*75 mg capsules\]) once daily on Day 1 and moxifloxacin placebo (matching 400 mg moxifloxacin \[1\*400 mg capsule\]) as a single dose on Day 1, 2, 15 and 16 along with ODV 25 mg (1\*25 mg tablet) and SMV 150 mg (2\*75 mg capsule) once daily on Day 2 to 16 and AL-335 1200 mg (3\*400 mg tablet) single dose on Day 15 orally under fed conditions. |
| Panel 2: Treatment E | PLACEBO_COMPARATOR | Participants will receive ODV placebo (matching 200 mg ODV \[4\*50 mg tablets\]) on Days 1 and 2; ODV placebo (matching 125 mg ODV \[2\*50 mg tablets + 1\*25 mg tablets\]) on Days 3 to 7; and ODV placebo (matching 100 mg ODV \[2\*50 mg tablets\] on Days 8 to 14, orally once daily under fed conditions. |
| Panel 2: Treatment F | EXPERIMENTAL | Participants will receive ODV 200 mg (4\*50 mg tablets) on Days 1 and 2; ODV 125 mg (2\*50 mg tablets + 1\*25 mg tablets) on Days 3 to 7, and ODV 100 mg (2\*50 mg tablets) on Days 8 to 14, orally once daily under fed conditions. |
| Name | Type | Description |
|---|---|---|
| ODV Placebo (Matching 25 mg ODV) | DRUG | Participants will receive ODV placebo (matching 25 \[mg\] ODV \[1\*25 mg tablet\]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1. |
| ODV Placebo (Matching 200 mg ODV) | DRUG | Participants will receive ODV placebo (matching 200 mg ODV \[4\*50 mg tablets\]) on Days 1 and 2 in Treatment E. |
| ODV Placebo (Matching 125 mg ODV) | DRUG | Participants will receive ODV placebo (matching 125 mg ODV \[2\*50 mg tablets + 1\*25 mg tablets\]) orally once daily on Days 3 to 7 in Treatment E. |
| ODV Placebo (Matching 100 mg ODV) | DRUG | Participants will receive ODV placebo (matching 100 mg ODV \[2\*50 mg tablets\] orally once daily on Days 8 to 14 in Treatment E. |
| SMV Placebo (Matching 150 mg SMV) | DRUG | Participants will receive SMV Placebo (matching 150 mg SMV \[2\*75 mg capsules\]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C. |
| AL-335 Placebo (matching 1200 mg AL-335) | DRUG | Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 \[3\*400 mg tablets\]) administered orally on Day 15 in Treatment A and B. |
| Moxifloxacin Placebo (matching 400 mg moxifloxacin) | DRUG | Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin \[1\*400 mg capsule\]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C. |
| ODV 25 mg | DRUG | Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C. |
| ODV 200 mg | DRUG | Participants will receive ODV 200 mg (4\*50 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F. |
| ODV 125 mg | DRUG | Participants will receive ODV 125 mg (2\*50 mg tablets + 1\*25 mg tablets) once daily administered on Days 3 to 7 in Treatment F. |
| ODV 100 mg | DRUG | Participants will receive ODV 100 mg (2\*50 mg tablets) orally once daily administered on Days 8 to 14 in Treatment F. |
| SMV 150 mg | DRUG | Participants will receive SMV 150 mg (2\*75 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C. |
| AL-335 1200 mg | DRUG | Participants will receive a single oral dose of AL-335 1200 mg (3\*400 mg tablets) administered on Day 15 in Treatment C. |
Inclusion Criteria: * Participants must sign and date an informed consent form (ICF) indicating that he or she understands the purpose of, and the procedures required for, the study and is willing to participate in the study * Participant must be healthy on the basis of physical examination, medica...