Conditions: Healthy Volunteers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 11
Healthy volunteers: yes

Brief summary:
A Phase 1b/2a, Randomized, Multi-Center, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Oral SYN-004 on the Pharmacokinetics of Intravenous Ceftriaxone in Healthy Adult Subjects with a Functioning Ileostomy.

Detailed description:
This is a Phase 1b/2a, randomized, multi-center, open-label study. Twenty otherwise healthy subjects between the ages of 18 and 80 years, inclusive, with functioning ileostomies were planned to be enrolled. In the first treatment period (Period 1) all subjects received an IV infusion of 1 g ceftriaxone. Subjects had a 3 - 7 day washout period between Period 1 and Period 2. In the second treatment period (Period 2) all subjects received an IV infusion of 1 g ceftriaxone and 2 oral doses of either 75 or 150 mg of SYN-004, according to the randomization schedule, which were administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion.

Arms:
arm 1: Treatment Sequence AB:

* Period 1: Ceftriaxone 1 g infused IV over 30 minutes
* \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\] arm 2: * Period 1: Ceftriaxone 1 g infused IV over 30 minutes
* \[Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion\] arm 3: 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 arm 4: * \[Period 1: Ceftriaxone 1 g infused IV over 30 minutes\]
* 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

Interventions: intervention 1: Period 1 - Treatment Sequence AB intervention 2: Period 1 - Treatment Sequence AC intervention 3: Period 2 - Treatment Sequence AB intervention 4: Period 2 - Treatment Sequence AC
Intervention descriptions: intervention 1: Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 intervention 2: Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004 intervention 3: Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg intervention 4: Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg

Protocol document: