Study Evaluating Single Ascending Doses of MR1817

Mochida Pharmaceutical

Status and phase: Completed; Phase 1

Conditions: Adult

Treatments: Drug: Placebo; Drug: MR1817

Study type: Interventional

Funder types: Industry

Identifiers

NCT00960180

3260A1-1000

Details and patient eligibility

About

This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects.

Enrollment: 64 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria: 1- Men or women of non-childbearing potential (WONCBP) aged 18 to 55 years inclusive at screening.

2- Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg. 3- Healthy as determined by the investigator on the basis of screening evaluations.

Exclusion criteria: 1- Presence or history of any disorder that may prevent the successful completion of the study. 2- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. 3- History of drug abuse within 1 year before study day 1.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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64 participants in 2 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: MR1817

2

Placebo Comparator group

Treatment:

Drug: Placebo