Pharmacokinetics and Safety Study of ME1100 in Healthy Volunteers

Meiji Seika Pharma

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: ME1100 placebo inhalation solution

Drug: ME1100 inhalation solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT01907776

ME1100-CL-101

Details and patient eligibility

About

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.

Enrollment

56 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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
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.