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Trial record 3 of 17 for:    "Noonan syndrome 5"

TD-6450 SAD and MAD in Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier:
NCT02022306
First received: December 17, 2013
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Hepatitis C
Drug: TD-6450
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Theravance Biopharma R & D, Inc.:

Primary Outcome Measures:
  • Adverse events [ Time Frame: 28 days max ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax [ Time Frame: 28 days max ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Tmax [ Time Frame: 28 days max ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • AUC [ Time Frame: 28 days max ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • T1/2 [ Time Frame: 28 days max ] [ Designated as safety issue: No ]
    Pharmacokinetics

  • Food effect on AUC value [ Time Frame: 15 days max ] [ Designated as safety issue: No ]
    Measure difference between fasted and fed doses


Enrollment: 111
Study Start Date: February 2014
Study Completion Date: September 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022306

Locations
United States, Texas
ICON Development Solutions
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Theravance Biopharma R & D, Inc.
  More Information

No publications provided

Responsible Party: Theravance Biopharma R & D, Inc.
ClinicalTrials.gov Identifier: NCT02022306     History of Changes
Other Study ID Numbers: 0094
Study First Received: December 17, 2013
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Theravance Biopharma R & D, Inc.:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014