Drug SafetyPhase 1NCT01355016
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers
A Phase 1 study testing MDT-637 in people with Drug Safety and Respiratory Syncytial Virus Infections, run by MicroDose Therapeutx, Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Safety, Respiratory Syncytial Virus Infections
- What is being tested?
- MDT-637
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Nov 2011
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception until they are discharged from the study
- Willing to give written informed consent
- 18 to 50 years of age
- BMI of 19-30 Kg/m2
- Non-smoker (for at least 90 days 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, ECG and clinical laboratory tests
- Willing to abstain from alcohol, caffeine, and xanthine-containing beverages for 24 hours prior to and 24 hours after dosing
Who cannot join
- Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and MDT would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
- Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- History of significant nasal irritation from nasal inhalation of medication
- History of malignancy
- History of clinically significant alcohol or drug abuse
- Positive drug screen for drugs of abuse
Show all 14Show fewer
- Positive test for HIV, Hepatitis B or Hepatitis C
- Allergy to lactose, or lactose intolerance
- Use of prescription medication within 14 days of Visit 2 or over-the-counter preparations, including dietary and herbal supplements, within 5 days of Visit 2
- Positive serum pregnancy test at Visit 1
- Inability to perform reproducible spirometry
- Abnormal FEV1, FVC, or FEV1/FVC (FEV1and FVC < 85% of predicted and variability of <5% or FEV1/FVC ratio < 0.7)
- Abnormal QTc interval at Visit 1(>450 msec in males or > 470 msec in females)
- Significant blood donation (or testing) in previous 8 weeks
Trial locations and contacts
1 site in 1 country.
United States1 site
West Coast Clinical Trials
Cypress, California, 90630
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled MDT-637 in Healthy Volunteers
The purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.
- Being tested
- MDT-637
- Keywords
- RSV
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MDT-637Drug
Inhaled doses of MDT-637 over a 24 hour period
| Study group | Role | What they receive |
|---|---|---|
| MDT-637 | Experimental | Active formulation Receives: Drug: MDT-637 |
| Placebo | Placebo comparator | Matched Placebo Comparator Receives: Drug: MDT-637 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.
Measured: Up to 22 days (including 14 day screening period)
Secondary outcomes (4)
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax
Measured: Multiple plasma samples collected up to 24 hours post first dose
Trough MDT-637 Nasal Concentration
Determination of MDT-637 concentration following nasal wash
Measured: 24 hours
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Tmax
Measured: 24 hours
Plasma pharmacokinetics of MDT-637 dry powder inhalation
Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by AUC
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug SafetyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroDose Therapeutx, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01355016
- Sponsor's protocol ID
- MDT-637-CP-101
- Status last verified
- Apr 2012
- First submitted
- 11 May 2011
- Last updated
- 12 Apr 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2012. 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 Inhaled MDT-637 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01355016
- Acronym / sponsor ID
- MDT-637-CP-101
- Keywords
- RSV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- MicroDose Therapeutx, IncIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 17 May 2011 (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 purpose of this study is to determine the range of single inhaled doses of a new dry powder product, MDT-637, that are safe and well-tolerated. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDT-637 | Experimental | Drug: MDT-637Active formulation |
| Placebo | Placebo comparator | Drug: MDT-637Matched Placebo Comparator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Males and/or surgically sterile or post-menopausal females (confirmed by FSH test); males must agree to practice barrier contraception until they are discharged from the study
- Willing to give written informed consent
- 18 to 50 years of age
- BMI of 19-30 Kg/m2
- Non-smoker (for at least 90 days prior to screening) and willing to abstain from smoking during the course of the study
Key exclusion criteria (14 listed)
- Uncontrolled, clinically significant disease which in the opinion of the Principal Investigator and MDT would place the subject at risk through study participation or would confound the assessment of the safety of MDT-637
- Evidence of current or history of respiratory disease, including asthma, emphysema, chronic bronchitis, or cystic fibrosis
- History of significant nasal irritation from nasal inhalation of medication
- History of malignancy
- History of clinically significant alcohol or drug abuse
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 |
|---|---|---|
| MDT-637Inhaled doses of MDT-637 over a 24 hour period | Drug | MDT-637, Placebo |
Primary outcome
Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers
Time frame: Up to 22 days (including 14 day screening period)
Safety measurements include Clinical Laboratory Evaluations, Pulmonary Function Tests (Spirometry), ECG, Vital Signs, Physical Examination and Assessment of Adverse Events.
4 secondary outcomes
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Time frame: Multiple plasma samples collected up to 24 hours post first dose
Trough MDT-637 Nasal Concentration
Time frame: 24 hours
Plasma pharmacokinetics for MDT-637 dry powder inhalation
Time frame: 24 hours
Plasma pharmacokinetics of MDT-637 dry powder inhalation
Time frame: 24 hours
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 Apr 2012.
- Development Program InformationLink provided by the sponsor.
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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 MDT-637 in people with Drug Safety and Respiratory Syncytial Virus Infections, run by MicroDose Therapeutx, Inc 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 7 inclusion and 14 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 Apr 2012. 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?
Safety and Tolerability of 6 escalating doses of MDT-637 dry powder inhalation in healthy volunteers (time frame: Up to 22 days (including 14 day screening period)). 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 Apr 2012.