Bacterial InfectionsPhase 1NCT02214433
A Multiple Dose Study of Debio 1450 [Intravenous (IV) and Oral] in Healthy Volunteers
A Phase 1 study testing Debio 1450 IV Solution, Debio 1450 Tablet and Debio 1450 Capsule in people with Bacterial Infections, run by Debiopharm International SA at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Debio 1450 IV Solution, Debio 1450 Tablet and Debio 1450 Capsule
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to Feb 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Early Phase Clinical Unit
Baltimore, Maryland, 21225
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects
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:
Read more
- 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
- Being tested
- Placebo IV Solution, Debio 1450 IV Solution, Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule
- Keywords
- Antibiotic, Antibiotic Resistant Bacterial Infection
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo IV SolutionDrug
A sterile IV solution of 5% dextrose in water
Debio 1450 IV SolutionDrug
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 CapsuleDrug
Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule
Debio 1450 TabletDrug
Debio 1450 40 mg coated tablets
Debio 1450 CapsuleDrug
Debio 1450 40 mg capsules
Debio 1450 Oral SolutionDrug
Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water
PantoprazoleDrug
Pantoprazole 40 mg orally
| Study group | Role | What they receive |
|---|---|---|
| Part A Period 1 Debio 1450 IV Solution | Experimental | Part A Debio 1450 IV solution infused over two hours on Day 1 after fasting Receives: Drug: Debio 1450 IV Solution |
| Part A Period 2 Debio 1450 Tablet | Experimental | Debio 1450 Tablet oral dosing once on Day 5, after fasting Receives: Drug: Debio 1450 Tablet |
| Part A Period 3 Debio 1450 Tablet | Experimental | Debio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting Receives: Drug: Debio 1450 Tablet |
| Part A Period 4 Debio 1450 Tablet | Experimental | After preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting Receives: Drug: Debio 1450 Tablet; Drug: Pantoprazole |
| Part B Placebo All Cohorts | Placebo comparator | Placebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule Receives: Drug: Placebo IV Solution; Drug: Placebo Tablet or Capsule |
| Part B Debio 1450 Cohort 1 | Experimental | Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10 Receives: Drug: Debio 1450 IV Solution; Drug: Debio 1450 Tablet |
| Part B Debio 1450 Cohort 2a | Experimental | Debio 1450 IV solution, once daily on day 1 Receives: Drug: Debio 1450 IV Solution |
| Part B Debio 1450 Cohort 3 | Experimental | Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10 Receives: Drug: Debio 1450 IV Solution; Drug: Debio 1450 Capsule |
| Part B Debio 1450 Cohort 4 | Experimental | Debio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10 Receives: Drug: Debio 1450 IV Solution; Drug: Debio 1450 Capsule |
| Part B Debio 1450 Cohort 2b | Experimental | Debio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10 Receives: Drug: Debio 1450 IV Solution; Drug: Debio 1450 Capsule |
| Part C Debio 1450 | Experimental | 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). Receives: Drug: Debio 1450 IV Solution; Drug: Debio 1450 Capsule; Drug: Debio 1450 Oral Solution; Drug: Pantoprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with clinically significant change from baseline in safety parameters
Categories: vital signs, 12-lead electrocardiogram (ECG), clinical laboratory parameters, adverse events, pulmonary function, physical examination, concomitant medication
Measured: within 10 days post-dose
Maximum observed plasma concentration (Cmax) of Debio 1450 (prodrug) and Debio 1452 (active moiety)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Time of maximum observed plasma concentration (tmax) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Area under the plasma concentration-time curve (AUC) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Percentage of AUC(0-o) that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Elimination half-life (t1/2) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Terminal elimination rate constant (Az) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Mean residence time (MRT) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Apparent clearance following oral administration (CL/F) of Debio 1450 and Debio 1452
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Apparent volume of distribution of Debio 1450 and Debio 1452 during terminal phase (Vz/F)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Percentage of cumulative amount of unchanged Debio 1450 and Debio 1452 excreted in urine (Ae%)
Categories: Placebo Tablet or Capsule, Placebo IV Solution, Debio 1450 IV solution, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Renal clearance following oral administration
Categories: Placebo Tablet or Capsule, Debio 1450 Tablet, Debio 1450 Capsule, Debio 1450 oral solution
Measured: within 60 hours post-dose, depending on the assessment schedule for the cohort
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Wittke, MD, Study director, Debiopharm International SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214433
- Sponsor's protocol ID
- Debio 1450-103
- Other IDs
- 217595
- Status last verified
- Feb 2015
- First submitted
- 8 Aug 2014
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Debio 1450 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02214433
- Acronym / sponsor ID
- Debio 1450-103
- Conditions
- Bacterial Infections
- Keywords
- Antibiotic, Antibiotic Resistant Bacterial Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A Period 1 Debio 1450 IV Solution | Experimental | Drug: Debio 1450 IV SolutionPart A Debio 1450 IV solution infused over two hours on Day 1 after fasting |
| Part A Period 2 Debio 1450 Tablet | Experimental | Drug: Debio 1450 TabletDebio 1450 Tablet oral dosing once on Day 5, after fasting |
| Part A Period 3 Debio 1450 Tablet | Experimental | Drug: Debio 1450 TabletDebio 1450 Tablet oral dosing once on Day 9, 30 minutes after a high calorie, high fat breakfast, after fasting |
| Part A Period 4 Debio 1450 Tablet | Experimental | Drug: Debio 1450 Tablet, Drug: PantoprazoleAfter preparation with Pantoprazole, Pantoprazole taken with Debio 1450 Tablet oral dosing once on Day 14, after fasting |
| Part B Placebo All Cohorts | Placebo comparator | Drug: Placebo IV Solution, Drug: Placebo Tablet or CapsulePlacebo IV solution on days 1-5 and then Placebo Tablet or Capsule on Days 6-10, according to the cohort dosing schedule |
| Part B Debio 1450 Cohort 1 | Experimental | Drug: Debio 1450 IV Solution, Drug: Debio 1450 TabletDebio 1450 IV solution, once daily on days 1-5, then Debio 1450 Tablet, once daily on days 6-10 |
| Part B Debio 1450 Cohort 2a | Experimental | Drug: Debio 1450 IV SolutionDebio 1450 IV solution, once daily on day 1 |
| Part B Debio 1450 Cohort 3 | Experimental | Drug: Debio 1450 IV Solution, Drug: Debio 1450 CapsuleDebio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10 |
| Part B Debio 1450 Cohort 4 | Experimental | Drug: Debio 1450 IV Solution, Drug: Debio 1450 CapsuleDebio 1450 IV solution, twice daily on days 1-5, then Debio 1450 Capsule, twice daily on days 6-10 |
| Part B Debio 1450 Cohort 2b | Experimental | Drug: Debio 1450 IV Solution, Drug: Debio 1450 CapsuleDebio 1450 IV solution, once daily on days 1-5, then Debio 1450 Capsule, once daily on days 6-10 |
| Part C Debio 1450 | Experimental | Drug: Debio 1450 IV Solution, Drug: Debio 1450 Capsule, Drug: Debio 1450 Oral Solution, Drug: PantoprazoleDebio 1450 (IV formulation in Period 1, capsule formulation in Periods 2, 4 and 5 (with Pantoprazole), and Debio 1450 oral solution in Period 3). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo IV SolutionA sterile IV solution of 5% dextrose in water | Drug | Part B Placebo All Cohorts |
| Debio 1450 IV SolutionA 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 | Part A Period 1 Debio 1450 IV Solution, Part B Debio 1450 Cohort 1, Part B Debio 1450 Cohort 2a, Part B Debio 1450 Cohort 2b, Part B Debio 1450 Cohort 3, Part B Debio 1450 Cohort 4, Part C Debio 1450 |
| Placebo Tablet or CapsulePlacebo tablet or capsule, matching Debio 1450 coated tablet or capsule | Drug | Part B Placebo All Cohorts |
| Debio 1450 TabletDebio 1450 40 mg coated tablets | Drug | Part A Period 2 Debio 1450 Tablet, Part A Period 3 Debio 1450 Tablet, Part A Period 4 Debio 1450 Tablet, Part B Debio 1450 Cohort 1 |
| Debio 1450 CapsuleDebio 1450 40 mg capsules | Drug | Part B Debio 1450 Cohort 2b, Part B Debio 1450 Cohort 3, Part B Debio 1450 Cohort 4, Part C Debio 1450 |
| Debio 1450 Oral SolutionLyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water | Drug | Part C Debio 1450 |
| PantoprazolePantoprazole 40 mg orally | Drug | Part A Period 4 Debio 1450 Tablet, Part C Debio 1450 |
Primary outcome
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
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
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Wittke, MD study director
Debiopharm International SA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Debio 1450 IV Solution, Debio 1450 Tablet and Debio 1450 Capsule in people with Bacterial Infections, run by Debiopharm International SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with clinically significant change from baseline in safety parameters (time frame: within 10 days post-dose). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2015.