HealthyPhase 1NCT01907776
Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers
A Phase 1 study testing ME1100 inhalation solution in people with Healthy, run by Meiji Seika Pharma Co., Ltd. at 1 site in United States.
Trial summary
This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). 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?
- ME1100 inhalation solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Dec 2013
- 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
- Male (who are surgically sterile or agree to practice barrier contraception throughout their participation in the study) or Female (using oral or double barrier contraceptive if sexually active, surgically sterile or post-menopausal confirmed by follicle stimulation hormone test);
- Willing to give written informed consent
- 18 to 55 years of age at time of consent
- Body Mass Index of 18-30 kg/m2
- Non-smoker (for at least 6 months prior to screening) and willing to abstain from smoking during the course of the study
- Good general health as determined by medical history, physical examination, 12-lead electrocardiograms and clinical laboratory tests (including normal renal function and high frequency audiometry)
- Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 72 hours after dosing.
- Japanese subjects must be first generation Japanese (4 grandparents, biologic parents and subject born in Japan)
Who cannot join
- Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator or Medical Monitor would place the subject at risk through study participation or would confound the assessment of the safety of ME1100 inhalation solution
- Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- History or current symptom(s) of respiratory tract inflammation within 30 days of Visit 2
- History of hearing, balance or ear disorder or surgery or injury to the ears, or with genetic mutation (>5.0% heteroplasmy) suggestive of increased risk of hearing loss (MT-RNR1 [A1555G] for mitochondrial 12S ribosomal RNA gene or MT-TS1 [A3243G] for mitochondrial transfer RNA serine 1)
- History of parent, sibling or parental sibling reporting hearing loss before age 65 years
- History of malignancy
Show all 18Show fewer
- History of clinically significant alcohol or drug abuse
- History within last 6 months or current use of any tobacco product including e-cigarettes
- Positive drug screen for drugs of abuse
- Positive test for HIV, Hepatitis B or Hepatitis C
- Use of any prescription or over-the-counter medications (except oral or hormonal contraceptives), herbal supplements, or vitamins within 14 days of Visit 2
- Known hypersensitivity to any aminoglycoside or bacitracin antibiotic
- Female of childbearing potential with a positive urine pregnancy test, or currently breast feeding.
- Inability to perform reproducible spirometry in accordance with American Thoracic Society (ATS) guidelines
- Abnormal Forced Expiratory Volume in the First Second (FEV1), Forced Vital Capacity (FVC), or FEV1/FVC (FEV1 or FVC < 80% of predicted or FEV1/FVC ratio < 0.7)
- FEV1 variability > 10% between Visit 1 and Visit 2 (prior to dosing)
- Significant blood donation (or testing) in previous 8 weeks before screening.
- Use of any Investigational Product in previous 30 days or 5 half-lives, whichever is longer, preceding start of screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ME1100 Inhalation Solution (Arbekacin Inhalation Solution) Administered to Healthy Volunteers
This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.
- Conditions
- Healthy
- Being tested
- ME1100 inhalation solution, ME1100 placebo inhalation solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ME1100 inhalation solutionDrug
Also called arbekacin, ME1100
ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose
ME1100 placebo inhalation solutionDrug
Vehicle placebo
| Study group | Role | What they receive |
|---|---|---|
| ME1100 | Experimental | ME1100 inhalation solution (arbekacin for oral inhalation at 150 mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose Receives: Drug: ME1100 inhalation solution |
| Placebo | Placebo comparator | ME1100 placebo inhalation solution Receives: Drug: ME1100 placebo inhalation solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events
Measured: from Baseline to Day 8-10
Number of participants with abnormal physical examinations
Measured: from Baseline to Day 8-10
Number of participants with abnormal 12-lead electrocardiograms
Measured: from Baseline to Day 8-10
Number of participants with abnormal vital signs
Measured: from Baseline to Day 8-10
Number of participants with abnormal safety laboratory measurements
Measured: from Baseline to Day 8-10
Secondary outcomes (2)
Serum Concentration of ME1100
Measured: 5, 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 18 and 24 hours post START of dosing
Urinary elimination of ME1100
Measured: 0-6, 6-12, 12-24, 24-48 and 48-72 hours after single dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mitsuharu Egawa, Study chair, Meiji Seika Pharma Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907776
- Sponsor's protocol ID
- ME1100-CL-101
- Status last verified
- Jun 2014
- First submitted
- 22 Jul 2013
- Last updated
- 12 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of ME1100 Inhalation Solution (Arbekacin Inhalation Solution) Administered to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01907776
- Acronym / sponsor ID
- ME1100-CL-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Meiji Seika Pharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- First posted
- 25 Jul 2013 (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.
This is a single-center, randomized, double-blind, placebo-controlled, sequential group study. The primary objective of this study is to assess the tolerability and safety of single doses of ME1100 inhalation solution (orally inhaled arbekacin). The secondary objective is to determine the systemic exposure to, and urinary elimination of, ME1100.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ME1100 | Experimental | Drug: ME1100 inhalation solutionME1100 inhalation solution (arbekacin for oral inhalation at 150 mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose |
| Placebo | Placebo comparator | Drug: ME1100 placebo inhalation solutionME1100 placebo inhalation solution |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Male (who are surgically sterile or agree to practice barrier contraception throughout their participation in the study) or Female (using oral or double barrier contraceptive if sexually active, surgically sterile or post-menopausal confirmed by follicle stimulation hormone test);
- Willing to give written informed consent
- 18 to 55 years of age at time of consent
- Body Mass Index of 18-30 kg/m2
- Non-smoker (for at least 6 months prior to screening) and willing to abstain from smoking during the course of the study
Key exclusion criteria (18 listed)
- Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator or Medical Monitor would place the subject at risk through study participation or would confound the assessment of the safety of ME1100 inhalation solution
- Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- History or current symptom(s) of respiratory tract inflammation within 30 days of Visit 2
- History of hearing, balance or ear disorder or surgery or injury to the ears, or with genetic mutation (>5.0% heteroplasmy) suggestive of increased risk of hearing loss (MT-RNR1 [A1555G] for mitochondrial 12S ribosomal RNA gene or MT-TS1 [A3243G] for mitochondrial transfer RNA serine 1)
- History of parent, sibling or parental sibling reporting hearing loss before age 65 years
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 |
|---|---|---|
| ME1100 inhalation solutionAlso: arbekacin, ME1100ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose | Drug | ME1100 |
| ME1100 placebo inhalation solutionVehicle placebo | Drug | Placebo |
Primary outcome
Number of participants with adverse events
Time frame: from Baseline to Day 8-10
Number of participants with abnormal physical examinations
Time frame: from Baseline to Day 8-10
Number of participants with abnormal 12-lead electrocardiograms
Time frame: from Baseline to Day 8-10
Number of participants with abnormal vital signs
Time frame: from Baseline to Day 8-10
Number of participants with abnormal safety laboratory measurements
Time frame: from Baseline to Day 8-10
2 secondary outcomes
Serum Concentration of ME1100
Time frame: 5, 15, 30 minutes and 1, 2, 3, 4, 6, 8, 12, 18 and 24 hours post START of dosing
Urinary elimination of ME1100
Time frame: 0-6, 6-12, 12-24, 24-48 and 48-72 hours after single dosing
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 12 Jun 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.
Mitsuharu Egawa study chair
Meiji Seika Pharma Co., Ltd.
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 ME1100 inhalation solution in people with Healthy, run by Meiji Seika Pharma Co., Ltd. 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 8 inclusion and 18 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 12 Jun 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 adverse events (time frame: from Baseline to Day 8-10). The study lists 5 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 12 Jun 2014.