Safety, Tolerability and Pharmacokinetics of 14-day Multiple Dose Titrations of TS-134 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Titration Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TS-134 Administered Orally to Healthy Male and Female Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03742791
• Other study ID #: TS134-US102
• Status: Completed
• Phase: Phase 1
• Start date: June 28, 2016
• Est. completion date: December 12, 2016

Study information

• Verified date: November 2018
• Source: Taisho Pharmaceutical R&D Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a Phase 1 study involving multiple dose titrations of TS-134 in healthy male and female subjects. The safety, tolerability and pharmacokinetics of multiple dose titrations of TS-134 will be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 12, 2016
• Est. primary completion date: December 12, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy adult male and female participants between 18 and 55 years of age

• Body weight greater than or equal to 45 kg

• Body Mass Index (BMI) greater than or equal to 18 and less than or equal to 30 kg/m^2

Exclusion Criteria:

• Female participants who are pregnant, intend to become pregnant, or are breastfeeding

• Clinically significant abnormal physical examination, 12-lead electrocardiogram (ECG) OR cardiac telemetry prior to dosing.

• Significant history or presence of hepatic, renal, cardiovascular, pulmonary, gastrointestinal, hematological, locomotor, immunologic, ophthalmologic, metabolic or oncological disease.

• History or presence of psychiatric or neurologic disease or condition

• History of alcohol or drug abuse

• Any participant who currently uses or has used tobacco or tobacco-containing products for at least one month prior to screening

• Participated in strenuous exercise within 48 hours prior to study start (initial dosing) and/or are unwilling to avoid strenuous exercise at any time throughout the study.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TS-134
5 mg to 80 mg oral solution
• Placebo
Matched Placebo oral solution

Locations

Country	Name	City	State
United States	PAREXEL - Early Phase Clinical Unit-Los Angeles	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Taisho Pharmaceutical R&D Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and Severity of Adverse Events		Day 1 to Day 21
Primary	TS-134 Plasma Pharmacokinetic Profile - Cmax	Maximum plasma concentration	Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose
Primary	TS-134 Plasma Pharmacokinetic Profile - AUC(0-tau)	Area under the plasma concentration vs time curve over a dosing interval	Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose
Primary	TS-134 Plasma Pharmacokinetic Profile - tmax	Time to maximum plasma concentration	Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose
Primary	TS-134 Plasma Pharmacokinetic Profile - t1/2	Apparent terminal elimination half-life	Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose
Primary	TS-134 Plasma Pharmacokinetic Profile - CL/F	Apparent clearance following oral administration	Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose
Primary	TS-134 Plasma Pharmacokinetic Profile - Vd/F	Apparent volumes of distribution following oral administration	Cohort 1: Day 1, Day 7, Day 8, Day 14, Cohort 2-3: Day 7, Day 14, Cohort 4-5: Day 9, Day 14, Cohort 6: Day 5, Day 14: predose, 0.25, 0.5, 1, 2, 3, 4, 5, 6, 8, 12h post-dose; Day 1 to Day 14 except above days: predose