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SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02657122
Recruitment Status : Completed
First Posted : January 15, 2016
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: TD-1473 for SAD Drug: Placebo for SAD Drug: TD-1473 for MAD Drug: Placebo for MAD Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Subjects
Study Start Date : December 2015
Actual Primary Completion Date : April 2016
Actual Study Completion Date : April 2016

Arm Intervention/treatment
Experimental: TD-1473 for SAD
6 of out 8 subjects per cohort will be randomized to receive TD-1473
Drug: TD-1473 for SAD
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.

Placebo Comparator: Placebo for SAD
2 of out 8 subjects per cohort will be randomized to receive placebo
Drug: Placebo for SAD
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.

Experimental: TD-1473 for MAD
6 of out 8 subjects per cohort will be randomized to receive TD-1473
Drug: TD-1473 for MAD
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.

Placebo Comparator: Placebo for MAD
2 of out 8 subjects per cohort will be randomized to receive placebo
Drug: Placebo for MAD
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs [ Time Frame: Day 1 through Day 8 (SAD) or 21 (MAD) ]

Secondary Outcome Measures :
  1. Area under curve (AUC) in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  2. Cmax in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  3. Tmax in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  4. Terminal elimination half-life (t1/2) in plasma, urine and feces [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  5. Amount excreted in urine (Aeu) [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  6. Amount excreted in feces (Aef) [ Time Frame: Day 1 through Day 4-6 (SAD) ]
  7. AUC in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  8. Cmax in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  9. Tmax in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  10. t1/2 in plasma, urine and feces [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  11. Aeu [ Time Frame: Day 1 through Day 17-19 (MAD) ]
  12. Aef [ Time Frame: Day 1 through Day 17-19 (MAD) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female 19 to 55 years old
  • Willing and able to give informed consent
  • Body Mass Index (BMI) 18 to 30 kg/m2
  • Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control
  • Additional inclusion criteria apply

Exclusion Criteria:

  • Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB)
  • Clinically significant abnormalities in baseline results of laboratory evaluations
  • 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
  • Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device)
  • Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy.
  • Additional exclusion criteria apply

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657122


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Study Director: Richard Graham, PhD Theravance Biopharma

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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02657122     History of Changes
Other Study ID Numbers: 0140
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Theravance Biopharma:
Single ascending dose
SAD
multiple ascending dose
MAD
Phase 1
first-in-human
volunteers
TD-1473