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TD-6450 SAD and MAD in Healthy Subjects

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

TD-6450

Placebo

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring Hepatitis C

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

ICON Development Solutions

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

SAD TD-6450

MAD TD-6450

Food effect of TD-6450

Arm Description

Single ascending dose (Part A)

Multiple ascending dose (Part B)

Food effect will be assessed in Part A (SAD) of this study.

Outcomes

Primary Outcome Measures

Adverse events

Secondary Outcome Measures

Cmax

Pharmacokinetics

Tmax

Pharmacokinetics

AUC

Pharmacokinetics

T1/2

Pharmacokinetics

Food effect on AUC value

Measure difference between fasted and fed doses

Full Information

NCT ID

NCT02022306

First Posted

December 17, 2013

Last Updated

January 12, 2021

Sponsor

Theravance Biopharma

1. Study Identification

Unique Protocol Identification Number

NCT02022306

Brief Title

TD-6450 SAD and MAD in Healthy Subjects

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theravance Biopharma

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C

Keywords

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

111 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SAD TD-6450

Arm Type

Placebo Comparator

Arm Description

Single ascending dose (Part A)

Arm Title

MAD TD-6450

Arm Type

Placebo Comparator

Arm Description

Multiple ascending dose (Part B)

Arm Title

Food effect of TD-6450

Arm Type

Active Comparator

Arm Description

Food effect will be assessed in Part A (SAD) of this study.

Intervention Type

Drug

Intervention Name(s)

TD-6450

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Adverse events

Time Frame

28 days max

Secondary Outcome Measure Information:

Title

Cmax

Description

Pharmacokinetics

Time Frame

28 days max

Title

Tmax

Description

Pharmacokinetics

Time Frame

28 days max

Title

AUC

Description

Pharmacokinetics

Time Frame

28 days max

Title

T1/2

Description

Pharmacokinetics

Time Frame

28 days max

Title

Food effect on AUC value

Description

Measure difference between fasted and fed doses

Time Frame

15 days max

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Theravance Biopharma

Official's Role

Study Director

Facility Information:

Facility Name

ICON Development Solutions

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78209

Country

United States

12. IPD Sharing Statement

Learn more about this trial

TD-6450 SAD and MAD in Healthy Subjects

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