NCT02214433

A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers

A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Debio 1450-103 is a trial to study the pharmacokinetics (PK) of an experimental drug called Debio 1450 in healthy adult volunteers. Originally, Part A was registered separately (in NCT02214355). The registrations have been revised so all parts of this single trial (Parts A-C) are now included in this single registration (NCT02214433). The primary purpose of each part is provided below: * 10 volunteers participate in PART A to assess the PK of a single oral dose of Debio 1450 (tablet formulation) under varying gastric conditions * 40 volunteers participate in PART B to assess the safety, tolerability and PK of multiple ascending doses of Debio 1450, administered sequentially IV and orally, once or twice daily. * An additional 10 volunteers participate in PART C which is designed to assess the absolute bioavailability of various formulations of Debio 1450 under varying gastric conditions The dose administered during Part A is based on the safety, tolerability and PK data from study Debio 1450-102 \[NCT02162199\], a single ascending dose (SAD) study, in which single oral doses up to 800 mg/day are being investigated. Doses are adjusted during Parts B and C based on the available safety and PK data from preceding cohorts.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
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

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2014-08-12
• Last updated: 2015-02-25

Locations

1 site across 1 country: United States