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CompletedNCT02022306Updated Jan 14, 2021

TD-6450 SAD and MAD in Healthy Subjects

A Phase 1 interventional study of TD-6450 and Placebo in Hepatitis C, sponsored by Theravance Biopharma. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-14.

Sponsored by Theravance Biopharma · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis C

Keywords

  • Hepatitis C
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 111 is above the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Theravance Biopharma is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
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

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).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
111 participants (actual)

Study arms

  • 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

Interventions

  • DrugTD-6450
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Adverse events

    Time frame: 28 days max

Secondary outcomes

  1. Cmax

    Pharmacokinetics

    Time frame: 28 days max

  2. Tmax

    Pharmacokinetics

    Time frame: 28 days max

  3. AUC

    Pharmacokinetics

    Time frame: 28 days max

  4. T1/2

    Pharmacokinetics

    Time frame: 28 days max

  5. Food effect on AUC value

    Measure difference between fasted and fed doses

    Time frame: 15 days max

07

Study locations

1 site
  • ICON Development Solutions
    San Antonio, Texas 78209, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02022306
Lead sponsor
Theravance Biopharma
Responsible party
Sponsor
First posted
Dec 27, 2013
Start date
Feb 2014
Primary completion
Aug 2014
Completion
Sep 2014
Last update
Jan 14, 2021

Study contacts

Medical Monitor
study director · Theravance Biopharma

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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