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Completed

NCT Number: NCT02214433

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

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.

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Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Early Phase Clinical Unit

Baltimore, Maryland, 21225, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • the safety or well-being of the participant or study staff
  • the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding)
  • the analysis of results

Treatment and study plan

Placebo IV Solution

Drug

A sterile IV solution of 5% dextrose in water

Debio 1450 IV Solution

Drug

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

Placebo Tablet or Capsule

Drug

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

Debio 1450 Tablet

Drug

Debio 1450 40 mg coated tablets

Debio 1450 Capsule

Drug

Debio 1450 40 mg capsules

Debio 1450 Oral Solution

Drug

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

Pantoprazole

Drug

Pantoprazole 40 mg orally

Primary outcomes

  1. Number of participants with clinically significant change from baseline in safety parameters

    Time frame: within 10 days post-dose

    Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication

  2. Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety)

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  3. Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  4. Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  5. Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  6. Elimination half-life (t1/2) of Debio 1450 and Debio 1452

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  7. Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  8. Mean residence time (MRT) of Debio 1450 and Debio 1452

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  9. Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  10. Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F)

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  11. Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae)

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  12. Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%)

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

  13. Renal clearance following oral administration

    Time frame: within 60 hours post-dose, depending on the assessment schedule for the cohort

    Categories: Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2014
Registry last updated
Feb 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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