TD-6450 SAD and MAD in Healthy Subjects

• Sponsor: Theravance Biopharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02022306
• Collaborator: (none)
• Enrollment: 111
• Location: 1
• Arms: 3
• Duration (Months): 7
• Patients Per Site Per Month: 15.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Drug: TD-6450; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 111 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: Feb 1, 2014
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Sep 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: SAD TD-6450 Single ascending dose (Part A)	Drug: TD-6450; Drug: Placebo
Placebo Comparator: MAD TD-6450 Multiple ascending dose (Part B)	Drug: TD-6450; Drug: Placebo
Active Comparator: Food effect of TD-6450 Food effect will be assessed in Part A (SAD) of this study.	Drug: TD-6450

Outcome Measures

Primary Outcome Measures

1. Adverse events [28 days max]

Secondary Outcome Measures

1. Cmax [28 days max]

   Pharmacokinetics

2. Tmax [28 days max]

   Pharmacokinetics

3. AUC [28 days max]

   Pharmacokinetics

4. T1/2 [28 days max]

   Pharmacokinetics

5. Food effect on AUC value [15 days max]

   Measure difference between fasted and fed doses

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ICON Development Solutions	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Theravance Biopharma

Investigators

• Study Director: Medical Monitor, Theravance Biopharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theravance Biopharma
• ClinicalTrials.gov Identifier: NCT02022306
• Other Study ID Numbers: 0094
• First Posted: Dec 27, 2013
• Last Update Posted: Jan 14, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Theravance Biopharma: Hepatitis C
• Additional relevant MeSH terms: Hepatitis C; Hepatitis

Study Results

No Results Posted as of Jan 14, 2021