Status:
COMPLETED
A Single Ascending and Repeated Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TS-142 in Healthy Participants
Lead Sponsor:
Taisho Pharmaceutical R&D Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a study to evaluate the safety, tolerability, and pharmacokinetics of single oral doses of TS-142 compared to placebo and of a single repeated dose compared to placebo in healthy volunteers. T...
Eligibility Criteria
Inclusion
- Healthy adult male and female participants between 18 and 55 years of age, inclusive
- Body weight ≥ 45 kg at screening and admission visits.
- Body Mass Index (BMI) ≥ 18 and ≤ 30 kg/m\^2 at screening visit.
Exclusion
- Clinically significant abnormal values for hematology, clinical chemistry or urinalysis at the screening and/or admission visits.
- Clinically significant abnormal physical examination (including neurological assessments), vital signs, or 12-lead ECGs at the screening and/or admission visits.
- QTcF \>450 msec for male participants or QTcF \>470 msec for female participants at the screening and/or admission visits.
- Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, neurological, immunologic, ophthalmologic, metabolic or oncological disease.
- History or present diagnosis of sleep disorders.
- Currently experiencing sleep disturbance related to postmenopausal symptoms at the screening and/or admission visits.
- History or presence of suicidal behavior, defined as participants who have answered 'YES' to any of the C-SSRS suicidal behavior questions at the screening and/or admission visits.
- Positive urine screen for alcohol or controlled substances at the screening or admission visits.
- Recent history (within the previous 6 months) of alcohol or drug abuse.
- Regular alcohol consumption of \> 2 units/day or 10 units/week during the last 3 months prior to screening. One unit is equivalent to 8 g of alcohol: a half pint (240 mL) of beer, a glass (125 mL) of wine, or 25 mL of spirits.
- Current use, or use of tobacco or tobacco-containing products (cigarettes, pipes, e-cigarettes, nicotine patches, etc.) during the month prior to screening, or positive urine cotinine screen (\>400 ng/mL) at the screening and/or admission visits.
- History of and/or current evidence of serologic positive results for hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or human immunodeficiency virus (HIV) antibodies 1 and 2.
- Donation of one or more units of blood, plasma (including platelet donations), or acute loss of an equivalent amount of blood within 60 days prior to screening visit (one unit= 450 mL).
- Exposure to any investigational product within 60 days prior to screening.
- Use of any prescription or over-the-counter medication, herbal medication, vitamins, or mineral supplements within 14 days prior to administration of the study drug.
- Participants who regularly consume \>500 mg of caffeine on a daily basis.
- Is known to be allergic to the study drug or any components of the study drug.
- Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or is unwilling to avoid strenuous exercise at any time throughout the study.
- Participants who work night shifts or need to work night shifts during the trial.
Key Trial Info
Start Date :
September 14 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 21 2021
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04464239
Start Date
September 14 2020
End Date
January 21 2021
Last Update
February 10 2021
Active Locations (1)
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1
PPD Phase I unit
Austin, Texas, United States, 78744