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

Debiopharm

Status and phase: Completed; Phase 1

Conditions: Bacterial Infections

Treatments: Drug: Debio 1450 Tablet; Drug: Placebo Tablet or Capsule; Drug: Debio 1450 IV Solution; Drug: Placebo IV Solution; Drug: Debio 1450 Capsule; Drug: Pantoprazole; Drug: Debio 1450 Oral Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT02214433

Debio 1450-103

217595 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Meets protocol-specified criteria for qualification and/or contraception
• Is willing and able to remain confined in the study unit for the entire duration of each treatment period and comply with restrictions related to food, drink and medications
• Voluntarily consents to participate and provides written informed consent prior to any protocol-specific procedures

Exclusion criteria

• Has a history or current use of over-the-counter medications, dietary supplements, or drugs (including nicotine and alcohol) outside protocol-specified parameters

• Has signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise:

  1. the safety or well-being of the participant or study staff
  2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  3. the analysis of results

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 11 patient groups, including a placebo group

Part A Period 1 Debio 1450 IV Solution

Experimental group

Description:

Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting

Treatment:

Drug: Debio 1450 IV Solution

Part A Period 2 Debio 1450 Tablet

Experimental group

Description:

Debio 1450 Tablet oral dosing once on Day 5, after fasting

Treatment:

Drug: Debio 1450 Tablet

Part A Period 3 Debio 1450 Tablet

Experimental group

Description:

Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting

Treatment:

Drug: Debio 1450 Tablet

Part A Period 4 Debio 1450 Tablet

Experimental group

Description:

After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting

Treatment:

Drug: Debio 1450 Tablet

Drug: Pantoprazole

Part B Placebo All Cohorts

Placebo Comparator group

Description:

Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule

Treatment:

Drug: Placebo IV Solution

Drug: Placebo Tablet or Capsule

Part B Debio 1450 Cohort 1

Experimental group

Description:

Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10

Treatment:

Drug: Debio 1450 IV Solution

Drug: Debio 1450 Tablet

Part B Debio 1450 Cohort 2a

Experimental group

Description:

Debio 1450 IV solution, once daily on day 1

Treatment:

Drug: Debio 1450 IV Solution

Part B Debio 1450 Cohort 3

Experimental group

Description:

Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10

Treatment:

Drug: Debio 1450 Capsule

Drug: Debio 1450 IV Solution

Part B Debio 1450 Cohort 4

Experimental group

Description:

Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10

Treatment:

Drug: Debio 1450 Capsule

Drug: Debio 1450 IV Solution

Part B Debio 1450 Cohort 2b

Experimental group

Description:

Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10

Treatment:

Drug: Debio 1450 Capsule

Drug: Debio 1450 IV Solution

Part C Debio 1450

Experimental group

Description:

Debio 1450 (IV formulation in Period 1, capsule formulation in Periods 2, 4 and 5 (with Pantoprazole), and Debio 1450 oral solution in Period 3).

Treatment:

Drug: Debio 1450 Oral Solution

Drug: Debio 1450 Capsule

Drug: Debio 1450 IV Solution

Drug: Pantoprazole