Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TBD11 · 1 trial · 1 indication
Number of participants with one or more treatment-emergent adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of participants with one or more serious adverse events, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of participants with one or more adverse events resulting in temporary interruption of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of participants with one or more adverse events resulting in permanent discontinuation of trial intervention, summarized overall and by severity, Investigator-assessed relationship to trial intervention, System Organ Class, and Preferred Term.
Number of participants with treatment-emergent clinical chemistry abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of participants with treatment-emergent hematology abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of participants with treatment-emergent coagulation abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of participants with treatment-emergent urinalysis abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline using the protocol-specified toxicity grading criteria.
Number of Cohort 3 participants with treatment-emergent lipid profile abnormalities, summarized by visit, worst post-baseline grade, and grade shift from baseline.
Change from baseline in systolic blood pressure, measured in millimeters of mercury (mmHg).
Change from baseline in diastolic blood pressure, measured in millimeters of mercury (mmHg)
Change from baseline in heart rate, measured in beats per minute (bpm)
Change from baseline in body temperature, measured in degrees Celsius (°C)
Change From Baseline in 12-Lead ECG Heart Rate Change from baseline in 12-lead ECG heart rate, measured in beats per minute (bpm)
Change From Baseline in RR Interval Change from baseline in RR interval, measured in milliseconds (ms).
Change From Baseline in PR Interval Change from baseline in PR interval, measured in milliseconds (ms).
Change From Baseline in QRS Duration Change from baseline in QRS duration, measured in milliseconds (ms).
Change From Baseline in QT Interval Change from baseline in QT interval, measured in milliseconds (ms).
Change from baseline in QT interval corrected for heart rate using Fridericia's formula (QTcF), measured in milliseconds (ms).
| Arm | Type | Description |
|---|---|---|
| Cohort 1 (TBD11 or placebo) | EXPERIMENTAL | Participants randomized 3:1 to receiveTBD11 300 mg or matching placebo once daily for up to 14 days |
| Cohort 2 Arm A | EXPERIMENTAL | Participants receive TBD11 50 mg single dose alone and in combination with itraconazole 200 mg BID loading dose followed by 200 mg QD. |
| Cohort 2 Arm B | EXPERIMENTAL | Participants receive TBD11 up to 300 mg single dose alone and in combination with rifampicin 600 mg QD. |
| Cohort 3 (TBD11 or placebo) | EXPERIMENTAL | Participants randomized 2:1 to receive TBD11 up to 300 mg or matching placebo once daily for up to 84 days |
| Name | Type | Description |
|---|---|---|
| TBD11 (300 mg) | DRUG | TBD11: TBD11 administered orally at 300 mg |
| Placebo | DRUG | Matching placebo administered orally according to the cohort-specific dosing schedule. |
| Itraconazole (200 mg) | DRUG | Itraconazole 200 mg orally once daily, with a 400 mg loading dose on the first day of administration. |
| Rifampicin 600mg | DRUG | Rifampicin 600 mg orally once daily. |
| TBD11 (50 mg) | DRUG | TBD11: TBD11 administered orally at 50 mg |
| TBD11 (up to 300 mg) | DRUG | TBD11: TBD11 administered orally at up to 300 mg |
Inclusion Criteria: * 18 to 55 years of age, inclusive. * Healthy, as determined by the Investigator through medical history and clinical examination before enrolment. * Able to understand and comply with trial and site procedures, understand study risks, and provide written informed consent before...