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

MicroDose Therapeutx

Status and phase

Completed

Phase 1

Conditions

Drug Safety

Treatments

Drug: MDT-637

Study type

Interventional

Funder types

Industry

Identifiers

NCT01489306

MDT-637-CP-102

Details and patient eligibility

About

The purpose of the study is to assess the tolerability and safety of a range of repeated inhaled doses of MDT-637. This includes monitoring effects on pulmonary function and determination of blood levels of MDT-637 following inhalation.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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, spirometry, 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 Sponsor (MDTx) 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; for instance asthma, emphysema, chronic bronchitis or cystic fibrosis.
Upper respiratory tract infection within 6 weeks of Visit 1
Symptoms of rhinitis (stuffy nose, rhinorrhea, sneezing, nasal discharge) within 2 weeks of Visit 1
Current symptoms of cough, dyspnea, wheezing or nocturnal awakenings due to respiratory symptoms
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 urine pregnancy test at Visit 1
Inability to perform reproducible spirometry in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines
Abnormal QTc interval at Visit 1(>450 msec in males or > 470 msec in females)
Significant blood donation (or testing) in previous 8 weeks