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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02419001 | A Study to Evaluate the Effect of SYN-004 on the PK of IV Ceftriaxone in Adults With a Functioning Ileostomy | PHASE1 | COMPLETED | 11 | — | — | Mar 1, 2015 | Oct 1, 2015 | Nov 27, 2018 | 3 | United States, Canada |
Samples were collected at 0.25 h, 0.5 through 2 h, and 3 through 7 h after the infusion start. Standard deviations may be 0 if all collected T max values occur at the same time.
| Arm | Type | Description |
|---|---|---|
| Period 1 - Treatment Sequence AB | EXPERIMENTAL | Treatment Sequence AB: * Period 1: Ceftriaxone 1 g infused IV over 30 minutes * \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\] |
| Period 1 - Treatment Sequence AC | EXPERIMENTAL | * Period 1: Ceftriaxone 1 g infused IV over 30 minutes * \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\] |
| Period 2 - Treatment Sequence AB | EXPERIMENTAL | Treatment Sequence AB: * \[Period 1: Ceftriaxone 1 g infused IV over 30 minutes\] * Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion |
| Period 2 - Treatment Sequence AC | EXPERIMENTAL | * \[Period 1: Ceftriaxone 1 g infused IV over 30 minutes\] * Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion |
| Name | Type | Description |
|---|---|---|
| Period 1 - Treatment Sequence AB | DRUG | Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 |
| Period 1 - Treatment Sequence AC | DRUG | Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 |
| Period 2 - Treatment Sequence AB | DRUG | Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg |
| Period 2 - Treatment Sequence AC | DRUG | Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg |
Inclusion Criteria: 1. The subject has a functioning ileostomy which has been in place for \> 3 months. 2. Male or female between the ages of 18 and 70 years, inclusive. 3. Other than a functioning ileostomy, the subject is free from clinically significant illnesses or disease. Exclusion Criteria:...