A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects

Tanabe Pharma America, Inc.

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: MT-6345 Placebo; Drug: MT-6345

Study type: Interventional

Funder types: Industry

Identifiers

NCT03809039

MT-6345-E01

2018-002478-39 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to Investigate the Safety, Tolerability and Pharmacokinetics of MT-6345 in Healthy Subjects.

Enrollment: 52 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Additional screening criteria check may apply for qualification:

• Able to provide written informed consent to participate in this study after reading the participant information sheet and Informed Consent Form (ICF), and after having the opportunity to discuss the study with the Investigator or designee.
• Healthy and free from clinically significant illness or disease as determined by medical history, physical examination, laboratory and other tests at Screening and Day -1.
• A body weight of ≥60 kg for males and ≥50 kg for females and a body mass index (BMI) (Quetelet index) ranging from 18 to 30.0 kg/m2 inclusive at Screening and Day -1.
• In the Investigator's opinion, subject is able to understand the nature of the study and any risks involved in participation, and willing to cooperate and comply with the Protocol restrictions and requirements.

Exclusion criteria

Additional screening criteria check may apply for qualification:

• Subjects with clinically significant (in the opinion of the Investigator) endocrine, thyroid, hepatic, respiratory, gastrointestinal, neurological, renal, cardiovascular disease, or history (within the last 5 years) of any significant psychiatric/psychotic illness disorder (including anxiety, depression and reactive depression).
• Female subjects who are pregnant (positive pregnancy test at Screening or Day -1) or lactating.
• Having previously received MT-6345 as part of this study.
• Clinically relevant abnormal medical history, physical findings or laboratory values at Screening or Day -1 that could interfere with the objectives of the study or the safety of the subject, as judged by the Investigator.
• Subjects who test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody, human immunodeficiency virus (HIV)-1 or HIV-2 antibodies at Screening.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups

Single Ascending Dose: MT-6345 & Placebo

Experimental group

Treatment:

Drug: MT-6345

Drug: MT-6345 Placebo

Multiple Ascending Dose: MT-6345 & Placebo

Experimental group

Treatment:

Drug: MT-6345

Drug: MT-6345 Placebo