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Completed

NCT Number: NCT02657122

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

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.

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Key information

Conditions

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TD-1473 for SAD

Drug

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 for SAD

Drug

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.

TD-1473 for MAD

Drug

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 for MAD

Drug

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 outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 15, 2016
Registry last updated
Jan 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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