TD-6450 SAD and MAD in Healthy Subjects

Phase 1

Completed

• Conditions: Hepatitis C
• Interventions: Drug: TD-6450; Drug: Placebo

• Registration Number: NCT02022306
• Lead Sponsor: Theravance Biopharma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-17
• Study First Submitted QC: 2013-12-20
• Study First Posted: 2013-12-27
• Study Start: 2014-02
• Primary Completion: 2014-08
• Study Completion: 2014-09
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SAD TD-6450	TD-6450	Single ascending dose (Part A)
SAD TD-6450	Placebo	Single ascending dose (Part A)
MAD TD-6450	TD-6450	Multiple ascending dose (Part B)
MAD TD-6450	Placebo	Multiple ascending dose (Part B)
Food effect of TD-6450	TD-6450	Food effect will be assessed in Part A (SAD) of this study.

Primary Outcome Measures

Name	Time	Method
Adverse events	28 days max

Secondary Outcome Measures

Name	Time	Method
Cmax	28 days max	Pharmacokinetics
T1/2	28 days max	Pharmacokinetics
Tmax	28 days max	Pharmacokinetics
Food effect on AUC value	15 days max	Measure difference between fasted and fed doses
AUC	28 days max	Pharmacokinetics

Trial Locations

Locations (1)

ICON Development Solutions; 🇺🇸 San Antonio, Texas, United States