TD-6450 SAD and MAD in Healthy Subjects

Hepatitis C Clinical Trial

Official title:

A Double-Blinded, Randomized, Placebo-Controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of TD-6450, a NS5A Inhibitor, in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02022306
• Other study ID #: 0094
• Status: Completed
• Phase: Phase 1
• Start date: February 2014
• Est. completion date: September 2014

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study consists of two parts, Parts A and B. Part A is a single ascending dose (SAD) study in healthy subjects. Part B is a multiple ascending dose (MAD) study in healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: September 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subject is a female of non-childbearing potential or male, who is healthy, nonsmoking, and 18 to 60 years old, inclusive, at screening. Females are considered to be of non childbearing potential if they have had a hysterectomy or tubal ligation (documentation required) or are postmenopausal (amenorrheic for at least 2 years) with a follicle stimulating hormone (FSH) level >40 IU/L

• Subject has a body mass index 18 to 30 kg/m2, inclusive, and weighs at least 50 kg.

Exclusion Criteria:

• Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.

• Subject has an estimated creatinine clearance of <90 mL/min at Screening or Day -1, calculated using the Cockcroft-Gault equation.

• Subject has participated in another clinical trial of an investigational drug (or medical device) within 60 days prior to Screening, or is currently participating in another trial of an investigational drug (or medical device).

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• TD-6450

• Placebo

Locations

Country	Name	City	State
United States	ICON Development Solutions	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events		28 days max
Secondary	Cmax	Pharmacokinetics	28 days max
Secondary	Tmax	Pharmacokinetics	28 days max
Secondary	AUC	Pharmacokinetics	28 days max
Secondary	T1/2	Pharmacokinetics	28 days max
Secondary	Food effect on AUC value	Measure difference between fasted and fed doses	15 days max