HealthyPhase 1NCT02897869
DDI Study to Investigate Interaction Between Amikacin and POL7080
A Phase 1 study testing POL7080, Amikacin and POL7080 + Amikacin in people with Healthy, run by Polyphor Ltd. at 1 site in Germany.
Trial summary
Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- POL7080, Amikacin and POL7080 + Amikacin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2016to Dec 2016
- 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
- Healthy male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
- BMI between 18.0-30.0 kg/m2
- Creatinine clearance estimated by Cockroft Gault formula > 80 mL/min and < 160 ml/min (for males), or < 150ml/min (females)
- Non smokers
- Normal audiogram.
Who cannot join
- History or suspicion of alcohol and/or drug abuse in the last 5 years
- Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
- Regular consumption of large amounts of xanthine
- Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
- Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
- Any signs of renal impairment
- Clinically significant abnormalities (e.g. cardiovascular, laboratory values)
- Clinically significant abnormal ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects
Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.
- Conditions
- Healthy
- Being tested
- POL7080, Amikacin, POL7080 + Amikacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POL7080Drug
7 doses of POL7080 alone over 2.5 days
AmikacinDrug
3 doses of Amikacin alone over 2.5 days
POL7080 + AmikacinDrug
7 doses of POL7080 and 3 doses of Amikacin over 2.5 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment sequence 1 | Experimental | Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, POL7080; Period 2, Amikacin; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment. Receives: Drug: POL7080; Drug: Amikacin; Drug: POL7080 + Amikacin |
| Treatment sequence 2 | Experimental | Participants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, Amikacin; Period 2, POL7080; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment. Receives: Drug: POL7080; Drug: Amikacin; Drug: POL7080 + Amikacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)
Measured: Up to 4 days for each period
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC)
Measured: Up to 4 days for each period
Secondary outcomes (1)
Incidence of adverse Events
Measured: up to 19 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Polyphor Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897869
- Sponsor's protocol ID
- POL7080-009
- Status last verified
- Jan 2017
- First submitted
- 2 Sep 2016
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Open-label, Two Sequence, Crossover Study to Investigate the Interaction Between Amikacin and POL7080 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02897869
- Acronym / sponsor ID
- POL7080-009
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Polyphor Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Sep 2016 (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.
Single-center, open-label, 2-sequence, 3-period crossover drug-drug interaction study. Repeated doses of POL7080 and repeated doses of amikacin will be administered alone or combined. In total, 14 subjects will be enrolled to obtain at least 10 evaluable subjects. The study consists of an eligibility screening period, up to 3 treatments periods and a follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment sequence 1 | Experimental | Drug: POL7080, Drug: Amikacin, Drug: POL7080 + AmikacinParticipants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, POL7080; Period 2, Amikacin; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment. |
| Treatment sequence 2 | Experimental | Drug: POL7080, Drug: Amikacin, Drug: POL7080 + AmikacinParticipants will be randomized to one of two treatment sequences. Sequence 1 is: Period 1, Amikacin; Period 2, POL7080; Period 3,POL7080+Amikacin. Each period is separated by a wash-out period of at least 12 days between last dose and start of next treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male and female (of non-childbearing potential) subjects between 18 to 55 years of age (inclusive)
- BMI between 18.0-30.0 kg/m2
- Creatinine clearance estimated by Cockroft Gault formula > 80 mL/min and < 160 ml/min (for males), or < 150ml/min (females)
- Non smokers
- Normal audiogram.
Key exclusion criteria (8 listed)
- History or suspicion of alcohol and/or drug abuse in the last 5 years
- Within 2 months prior to screening: exposure to aminoglycoside antibiotic, chemotherapy, or current use of loop diuretics
- Regular consumption of large amounts of xanthine
- Any medication that inhibits active tubular secretion within 4 weeks prior to first dosing
- Infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C (HCV)
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 |
|---|---|---|
| POL70807 doses of POL7080 alone over 2.5 days | Drug | Treatment sequence 1, Treatment sequence 2 |
| Amikacin3 doses of Amikacin alone over 2.5 days | Drug | Treatment sequence 1, Treatment sequence 2 |
| POL7080 + Amikacin7 doses of POL7080 and 3 doses of Amikacin over 2.5 days | Drug | Treatment sequence 1, Treatment sequence 2 |
Primary outcome
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax)
Time frame: Up to 4 days for each period
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate):Area under the plasma concentration versus time curve (AUC)
Time frame: Up to 4 days for each period
1 secondary outcome
Incidence of adverse Events
Time frame: up to 19 days
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 1 Feb 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 POL7080, Amikacin and POL7080 + Amikacin in people with Healthy, run by Polyphor Ltd. at 1 site in Germany.
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 5 inclusion and 8 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 1 Feb 2017. 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 Germany. 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. 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?
Multiple dose pharmacokinetics of POL7080 and Amikacin (as appropriate): Peak Plasma Concentration (Cmax) (time frame: Up to 4 days for each period). The study lists 2 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 1 Feb 2017.