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Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203 or placebo (6 active treatment : 2 placebo) in a fasting state.
Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a cohort, completes all procedures and none of the subjects has a clinically significant adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related serious adverse events (SAEs) have occurred.
A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100 mg dose level (this dose level may change based on PK analysis results). Subjects who received 100mg dose in a fasting state will return and receive the second dose, with food.
Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.
Randomized, double-blind, placebo-controlled, dose-escalation study in healthy male and female volunteers. Subjects will be randomly assigned to 1 of 7 treatment cohorts (Cohorts 1 - 7) of 8 subjects each, to receive either Q203 or placebo in a fasting state. Every attempt will be made to include at least 2 females in each cohort, at least one of whom will be assigned to receive Q203.
Dose escalation to the next cohort may be considered when at least 6 out of 8 subjects, in a cohort, completes all procedures and none of the subjects has a clinically significant adverse event (AE) that is being followed, or at the discretion of the PI if no drug-related SAEs have occurred. A food effect cohort will be enrolled to test administration of Q203 in a fed state, at 100 mg dose level (this dose level may change based on PK analysis results). Subjects who received 100mg dose in a fasting state will return and receive the second dose, with food. In this cohort, all eight subjects will proceed to receive either Q203 or placebo in a six to two ratio (six active treatment : 2 placebo). Every attempt will be made to include at least 2 females in this cohort, at least one of whom will be assigned to receive Q203.
Subjects will be followed up for AEs, SAE or pregnancy for 30 days postdrug administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Q203 | Experimental | Q203 drug products (10mg and 100mg tablets) |
|
| Placebo | Placebo Comparator | Placebo tablets (same excipients used in Q203 drug products) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Q203 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed through adverse events, vital signs, ECG, laboratory results, and telemetry monitoring | 7 days post dose |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic analysis: Area under the plasma concentration | predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose | |
| Pharmacokinetic analysis: Maximum observed plasma drug concentration | predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baltimore | Maryland | 21225 | United States |
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|
| Pharmacokinetic analysis: Time of maximum observed concentration | predose and 1, 2, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 216 and 312 hours postdose |
| ID | Term |
|---|---|
| C584497 | telacebec |
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