To Assess Pharmacokinetics, Safety and Tolerability of TEV-48125 in Japanese and Caucasian Healthy Subjects After a Single Subcutaneous (SC) Administration of TEV-48125

Pharmacokinetics Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of Single Doses Subcutaneous Administration of TEV-48125 (Doses up to 900 mg) in Japanese and Caucasian Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02673567
• Other study ID #: TV48125-PK-10078
• Status: Completed
• Phase: Phase 1
• Start date: March 31, 2016
• Est. completion date: February 10, 2017

Study information

• Verified date: December 2021
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single center, randomized, double-blind, placebo-controlled study to assess the pharmacokinetics, safety, and tolerability of subcutaneous administration of TEV-48125 (single ascending doses and single doses up to 900 mg) in Japanese and Caucasian healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: February 10, 2017
• Est. primary completion date: December 16, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• The subject is a man or woman, 18 to 55 years of age, inclusive

• The subject has a body mass index (BMI) ranging from 17.5 to 28.0 kg/m2, inclusive

• The subjects must be in a good health at screening and check-in

Additional inclusion criteria for Japanese subjects:

• Subject must be a non-naturalized Japanese citizen and hold a Japanese passport

• Subject must have/had 2 Japanese parents and 4 Japanese grandparents who are all non naturalized Japanese citizens

• Subject has been living outside of Japan for no more than 10 years

Additional inclusion criteria for Caucasian subjects:

• The subject has/had 2 Caucasian parents and 4 Caucasian grandparents. Caucasian includes White and Hispanic ethnicities.

• Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

• The subject is a woman who is pregnant or lactating

• The subject is suffering from, or has a clinically significant history of, 1 or more of the following: cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, hematologic or psychiatric disorder(s)

• The subject has a known allergy or sensitivity to injected proteins, including monoclonal antibodies, or any other component of the formulation. In addition, presence of history of allergies requiring acute or chronic treatment

• Precipitation in another clinical study of a new investigational drug within 30 days (90 days for biologics) before dosing

• Additional criteria apply, please contact the investigator for more information

Related Conditions & MeSH terms

• Pharmacokinetics

Intervention

Drug:
• TEV-48125 - 1
Subcutaneous administration Dose Regimen 1
• TEV-48125 - 2
Subcutaneous administration Dose Regimen 2
• TEV-48125 - 3
Subcutaneous administration Dose Regimen 3
• Placebo
Matching Placebo

Locations

Country	Name	City	State
United States	Teva Investigational Site 13529	Glendale	California

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma drug concentration (Cmax)		33 weeks
Primary	Time to maximum observed plasma drug concentration (tmax)		33 weeks
Primary	AUC from time 0 to the time of the last measurable plasma drug concentration (AUC0-t)		33 weeks
Primary	AUC from time 0 to 672 hours (4 weeks) postdose (AUC0-672)		33 weeks
Primary	AUC from time 0 extrapolated to infinity (AUC0-8)		33 weeks
Primary	Percentage extrapolated AUC (%AUCext)		33 weeks
Primary	Apparent serum terminal elimination rate constant (?z)		33 weeks
Primary	Apparent total body clearance (CL/F)		33 weeks
Primary	Apparent volume of distribution during the terminal phase (Vz/F)		33 weeks
Primary	Apparent serum terminal elimination half-life (t½)		33 weeks
Secondary	Percentage of Participants with Adverse Events		33 weeks
Secondary	Tolerability- Percentage of participants who fail to complete the study		33 weeks
Secondary	Percentage of participants who fail to complete the study due to adverse events		33 Weeks