NCT02214433 - A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

February 28, 2015

Study Completion Date

February 28, 2015

Conditions

Bacterial Infections

Interventions

DRUG

Placebo IV Solution

A sterile IV solution of 5% dextrose in water

DRUG

Debio 1450 IV Solution

A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water

DRUG

Placebo Tablet or Capsule

Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule

DRUG

Debio 1450 Tablet

Debio 1450 40 mg coated tablets

DRUG

Debio 1450 Capsule

Debio 1450 40 mg capsules

DRUG

Debio 1450 Oral Solution

Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water

DRUG

Pantoprazole

Pantoprazole 40 mg orally

Trial Locations (1)

Early Phase Clinical Unit, Baltimore