Bacterial InfectionsPhase 1NCT02162199
A Single Dose Study of Debio 1450 in Healthy Subjects
A Phase 1 study testing Debio 1450 in people with Bacterial Infections, run by Debiopharm International SA at 1 site in United States.
Trial summary
The sponsor is trying to develop a medicine for infections that are not cured by regular antibiotics. They have an experimental drug called Debio 1450 that may work. They need about 48 healthy adults to volunteer for this study. This study looks at what the body does to the drug. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Oct 2014
- 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
- Is a healthy adult
- Has met protocol-specified criteria for qualification and use of contraception
- Is willing and able to remain confined in the study unit for the entire duration of the treatment period and comply with restrictions related to food, drink and medications
- Has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures
Who cannot join
- Has screening laboratory values outside protocol-specified limits
- Has history of a clinically significant allergic drug reaction
- Has donated a volume of plasma or whole blood within a time frame not allowed per protocol
- Has historical or current use not allowed per protocol of:
- over-the-counter medications
- certain foods; dietary, mineral or herbal supplements
Show all 11Show fewer
- licit or illicit drugs (including experimental drugs, caffeine, nicotine and alcohol)
- 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, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Escalating Oral Doses of Debio 1450 in Healthy Subjects
The sponsor is trying to develop a medicine for infections that are not cured by regular antibiotics. They have an experimental drug called Debio 1450 that may work. They need about 48 healthy adults to volunteer for this study.
This study looks at what the body does to the drug. It measures how the amount of drug in blood and urine changes over time.
Read more
From the screening visit through the follow-up visit may be up to 40 days. Volunteers go to the clinic in Baltimore for a screening visit. The study doctor chooses qualified volunteers to participate or serve as alternates. Alternates might not actually complete the study procedures.
The study doctor divides participants into groups of eight. Six receive Debio 1450 and 2 receive Placebo. The drug each participant receives is decided by chance - like flipping a coin.
Eligible volunteers check into the clinic for testing and those chosen to participate remain for a 5-day/ 4-night stay. The clinic serves standard meals, except when fasting is required. Participants must stay at the clinic for the length of the study.
This study is a "dose escalation" study. That means that if no safety concerns come up a new group starts. Each new group of eight participants receives more capsules.
The study product is contained in capsules. Each capsule contains either placebo or 40 mg Debio 1450. After fasting overnight, the first two participants in the group receive their capsules. One gets Debio 1450 and one gets Placebo. If these participants tolerate side effects for 24 hours, the remaining six participants receive their assigned capsules.
The plan is to increase the dose for the next group. The study doctor reviews the measurements collected from each group after three days. He may decide to repeat, increase, or lower the dose or even stop the study. The most any participant receives is 800 mg in 20 capsules.
- Conditions
- Bacterial Infections
- Being tested
- Debio 1450, Placebo
- 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.
Debio 1450Drug
Single sentinel dosing of 40 mg per unit capsules is planned to escalate from 80 mg to 160, 320, 480, 640 and 800 mg, per respective dosing group. Doses may be modified based on review of available safety and pharmacokinetic (PK) data.
PlaceboDrug
Matching single sentinel dosing of placebo capsules is planned to escalate from 2 capsules to 4, 8, 12, 16 and 20 capsules, per respective dosing group. The number of capsules will match those delivering Debio 1450 for the group, as those doses may be modified based on review of available safety and pharmacokinetic (PK) data.
| Study group | Role | What they receive |
|---|---|---|
| Debio 1450 | Experimental | Debio 1450 40 mg, capsules, orally, once in the morning under fasted conditions Receives: Drug: Debio 1450 |
| Placebo | Placebo comparator | Placebo 0 mg, matching capsules, orally, once in the morning under fasted conditions Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with at least one treatment emergent adverse event (TEAE)
Measured: within 10 days post-dose
Maximum observed plasma concentration (Cmax) of Debio 1450
Measured: within 60 hours post-dose
Time of maximum observed plasma concentration (tmax) of Debio 1450
Measured: within 60 hours post-dose
Secondary outcomes (13)
Area under the plasma concentration-time curve (AUC) of Debio 1450
Categorical results will include from time zero to 24 hours post-dose (AUC0-24), from time zero to the last measured concentration (AUC0-t), and from time zero extrapolated to infinity (AUC0-∞).
Measured: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Percentage of AUC0-∞ that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450
Measured: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Elimination half-life (t½) of Debio 1450
Measured: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Terminal elimination rate constant (λz) of Debio 1450
Measured: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Mean residence time (MRT) of Debio 1450
Measured: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Apparent clearance following oral administration (CL/F) of Debio 1450
Measured: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Apparent volume of distribution of Debio 1450 during terminal phase (Vz/F)
Measured: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Cumulative amount of unchanged Debio 1450 excreted in urine (Ae)
Measured: pre-dose and 0-2, 2-6, 6-12, 12-24, 24-48 and 48-60 hours post-dose
Percentage of cumulative amount of unchanged Debio 1450 excreted in urine (Ae%)
Measured: pre-dose and 0-2, 2-6, 6-12, 12-24, 24-48 and 48-60 hours post-dose
Renal clearance following oral administration
Measured: pre-dose and 0-2, 2-6, 6-12, 12-24, 24-48 and 48-60 hours post-dose
Number of participants with clinically significant change from baseline in vital signs
Measured: within 10 days post-dose
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) parameters
Measured: within 48 hours post-dose
Number of participants with clinically significant change from baseline in clinical laboratory parameters
Measured: within 51 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionOct 2014
- Study completionOct 2014
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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Debiopharm International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Azra Hussaini, MD, Principal investigator, Early Phase Clinical Unit - Baltimore, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02162199
- Sponsor's protocol ID
- Debio 1450-102
- Other IDs
- 217596
- Status last verified
- Oct 2014
- First submitted
- 10 Jun 2014
- Last updated
- 23 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Escalating Oral Doses of Debio 1450 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02162199
- Acronym / sponsor ID
- Debio 1450-102
- Conditions
- Bacterial Infections
- Keywords
- Antibiotic, Antibiotic Resistant Bacterial Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Debiopharm International SAIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 12 Jun 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.
The sponsor is trying to develop a medicine for infections that are not cured by regular antibiotics. They have an experimental drug called Debio 1450 that may work. They need about 48 healthy adults to volunteer for this study.
This study looks at what the body does to the drug. It measures how the amount of drug in blood and urine changes over time.
From the screening visit through the follow-up visit may be up to 40 days. Volunteers go to the clinic in Baltimore for a screening visit. The study doctor chooses qualified volunteers to participate or serve as alternates. Alternates might not actually complete the study procedures.
The study doctor divides participants into groups of eight. Six receive Debio 1450 and 2 receive Placebo. The drug each participant receives is decided by chance - like flipping a coin.
Eligible volunteers check into the clinic for testing and those chosen to participate remain for a 5-day/ 4-night stay. The clinic serves standard meals, except when fasting is required. Participants must stay at the clinic for the length of the study.
This study is a "dose escalation" study. That means that if no safety concerns come up a new group starts. Each new group of eight participants receives more capsules.
The study product is contained in capsules. Each capsule contains either placebo or 40 mg Debio 1450. After fasting overnight, the first two participants in the group receive their capsules. One gets Debio 1450 and one gets Placebo. If these participants tolerate side effects for 24 hours, the remaining six participants receive their assigned capsules.
The plan is to increase the dose for the next group. The study doctor reviews the measurements collected from each group after three days. He may decide to repeat, increase, or lower the dose or even stop the study. The most any participant receives is 800 mg in 20 capsules.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debio 1450 | Experimental | Drug: Debio 1450Debio 1450 40 mg, capsules, orally, once in the morning under fasted conditions |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 0 mg, matching capsules, orally, once in the morning under fasted conditions |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Is a healthy adult
- Has met protocol-specified criteria for qualification and use of contraception
- Is willing and able to remain confined in the study unit for the entire duration of the treatment period and comply with restrictions related to food, drink and medications
- Has voluntarily consented to participate and provided written informed consent prior to any protocol-specific procedures
Key exclusion criteria (11 listed)
- Has screening laboratory values outside protocol-specified limits
- Has history of a clinically significant allergic drug reaction
- Has donated a volume of plasma or whole blood within a time frame not allowed per protocol
- Has historical or current use not allowed per protocol of:
- 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 |
|---|---|---|
| Debio 1450Single sentinel dosing of 40 mg per unit capsules is planned to escalate from 80 mg to 160, 320, 480, 640 and 800 mg, per respective dosing group. Doses may be modified based on review of available safety and pharmacokinetic (PK) data. | Drug | Debio 1450 |
| PlaceboMatching single sentinel dosing of placebo capsules is planned to escalate from 2 capsules to 4, 8, 12, 16 and 20 capsules, per respective dosing group. The number of capsules will match those delivering Debio 1450 for the group, as those doses may be modified based on review of available safety and pharmacokinetic (PK) data. | Drug | Placebo |
Primary outcome
Number of participants with at least one treatment emergent adverse event (TEAE)
Time frame: within 10 days post-dose
Maximum observed plasma concentration (Cmax) of Debio 1450
Time frame: within 60 hours post-dose
Time of maximum observed plasma concentration (tmax) of Debio 1450
Time frame: within 60 hours post-dose
13 secondary outcomes
Area under the plasma concentration-time curve (AUC) of Debio 1450
Time frame: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Percentage of AUC0-∞ that is due to extrapolation beyond the last quantifiable concentration measurement (%AUCex) of Debio 1450
Time frame: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Elimination half-life (t½) of Debio 1450
Time frame: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Terminal elimination rate constant (λz) of Debio 1450
Time frame: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Mean residence time (MRT) of Debio 1450
Time frame: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Apparent clearance following oral administration (CL/F) of Debio 1450
Time frame: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Apparent volume of distribution of Debio 1450 during terminal phase (Vz/F)
Time frame: pre-dose, 15, 30 and 60 minutes post-dose, and 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 30, 36, 48 and 60 hours post-dose
Cumulative amount of unchanged Debio 1450 excreted in urine (Ae)
Time frame: pre-dose and 0-2, 2-6, 6-12, 12-24, 24-48 and 48-60 hours post-dose
Percentage of cumulative amount of unchanged Debio 1450 excreted in urine (Ae%)
Time frame: pre-dose and 0-2, 2-6, 6-12, 12-24, 24-48 and 48-60 hours post-dose
Renal clearance following oral administration
Time frame: pre-dose and 0-2, 2-6, 6-12, 12-24, 24-48 and 48-60 hours post-dose
Number of participants with clinically significant change from baseline in vital signs
Time frame: within 10 days post-dose
Number of participants with clinically significant change from baseline in 12-lead electrocardiogram (ECG) parameters
Time frame: within 48 hours post-dose
Number of participants with clinically significant change from baseline in clinical laboratory parameters
Time frame: within 51 hours post-dose
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 23 Oct 2014.
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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.
Azra Hussaini, MD principal investigator
Early Phase Clinical Unit - Baltimore, USA
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 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 4 inclusion and 11 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 23 Oct 2014. 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 at least one treatment emergent adverse event (TEAE) (time frame: within 10 days post-dose). The study lists 3 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 23 Oct 2014.