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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01162486 | Pharmacokinetics, Safety and Tolerability of Escalating Rifapentine Doses in Healthy Volunteers | PHASE1 | COMPLETED | 37 | — | — | Apr 1, 2010 | Mar 1, 2011 | May 7, 2019 | 1 | United States |
Number of Participants with Grade 2 or higher adverse events over 26 days
To determine and compare the steady-state pharmacokinetics and dose linearity of escalating daily doses of rifapentine in dose cohorts of 5 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kg in healthy volunteers after a single dose (Day 2) or multiple doses (Day 15)
| Arm | Type | Description |
|---|---|---|
| Rifampin control | ACTIVE_COMPARATOR | Rifampin + midazolam |
| RPT 1 | EXPERIMENTAL | RPT Cohort 1 - 5 mg/kg |
| RPT 2 | EXPERIMENTAL | RPT Cohort 2 - 10 mg/kg |
| RPT 3 | EXPERIMENTAL | RPT Cohort 3 - 15 mg/kg |
| RPT 4 | EXPERIMENTAL | RPT Cohort 4 - 20 mg/kg |
| RPT 5 | EXPERIMENTAL | RPT Cohort 5 - Maximal tolerated dose, if dose limiting toxicities are observed |
| Name | Type | Description |
|---|---|---|
| Rifampin & midazolam | DRUG | rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 |
| rifapentine & midazolam | DRUG | rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 |
| rifapentine and midazolam | DRUG | rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15 |
Inclusion Criteria: 1. Ability and willingness to provide written informed consent. 2. Age greater than or equal to 18 years, and less than or equal to 65 years. 3. Weight of 50-100 kg for enrollment into the RPT cohorts 4. Weight of 50-80 kg for enrollment into the RIF cohort 5. Within 28 or fewer...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Viatris, Inc. | VTRS | 1 | PHASE3 | Bedaquiline |
| Johnson & Johnson | JNJ | 1 | PHASE2 | Bedaquiline, Background Regimen |
| BioNTech SE Sponsored ADR | BNTX | 1 | PHASE1 | BNT164a1, BNT164b1 |
| Harvard Bioscience, Inc. | HBIO | 1 | — | Bdq, Lzd, Lfx, Dlm, Cfz |