A Trial to Assess the Safety, Tolerability, and Pharmacok... | NCT01355016

Studies
A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of MDT-637 in Healthy Volunteers

NCT01355016

Sponsor

MicroDose Therapeutx, Inc

Status

Completed

Last Update Posted

Apr 12, 2012Estimated

Enrollment

48Estimated

Phase

Phase 1

Conditions

Drug Safety
Respiratory Syncytial Virus Infections

Interventions

MDT-637

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Nov 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

May 11, 2011

First Submission Date that Met QC Criteria

May 16, 2011

First Posted Date

May 17, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2012

Last Update Posted Date

Apr 12, 2012Estimated

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MDT-637	Experimental	Active formulation	Drug: MDT-637
Placebo	Placebo Comparator	Matched Placebo Comparator	Drug: MDT-637

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MDT-637	Drug	Inhaled doses of MDT-637 over a 24 hour period	MDT-637 Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Up to 22 days (including 14 day screening period)

Secondary Outcomes

Measure	Description	Time Frame
Plasma pharmacokinetics for MDT-637 dry powder inhalation	Plasma samples will be measured to determine MDT-637 pharmacokinetics as defined by Cmax	Multiple plasma samples collected up to 24 hours post first dose
Trough MDT-637 Nasal Concentration

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D018186	Pneumovirus Infections
D018184	Paramyxoviridae Infections
D018701	Mononegavirales Infections
D012327	RNA Virus Infections