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Completed

NCT Number: NCT02903095

Single Ascending Dose Study of TD-1439 in Healthy Subjects

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 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

  • Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
  • Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
  • Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
  • Males must abstain from sex or use highly effective methods of birth control
  • Negative for HIV, and Hepatitis A, B, and C

Exclusion criteria

  • Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
  • Subjects with a history of angioedema.
  • 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 acute illness (gastrointestinal, infection [e.g., influenza] or known inflammatory process)
  • Subject bradycardia
  • Subject has hypertension
  • Subjects has orthostatic hypotension
  • Subjects has orthostatic tachycardia
  • Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
  • Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
  • Additional exclusion criteria apply

Treatment and study plan

TD-1439

Drug

Placebo

Drug

Primary outcomes

  1. Safety of TD-1439 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs

    Time frame: From Day 1 through end of study (Day 10)

Secondary outcomes

  1. Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)

    Time frame: Day 1 through Day 10

  2. PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)

    Time frame: Day 1 through Day 10

  3. PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)

    Time frame: Day 1 through Day 10

  4. PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)

    Time frame: Day 1 through Day 10

  5. PK of TD-1439 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)

    Time frame: Day 1 through Day 10

  6. PK of TD-1439 in plasma after multiple doses - CL/F (oral plasma clearance)

    Time frame: Day 1 through Day 10

  7. PK of TD-1439 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)

    Time frame: Day 1 through Day 10

  8. PK of TD-1439 in plasma after multiple doses - t1/2 (half-life)

    Time frame: Day 1 through Day 10

  9. PK of TD-1439 in urine after multiple doses - Ae (amount excreted in urine)

    Time frame: Day 1 through Day 10

  10. PK of TD-1439 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)

    Time frame: Day 1 through Day 10

  11. PK of TD-1439 in urine after multiple doses - Clr (renal clearance)

    Time frame: Day 1 through Day 10

  12. Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations

    Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)

  13. Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations

    Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)

  14. Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations

    Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)

  15. Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations

    Time frame: The day before dosing (Day -1) to 3 days after last dose (Day 4)

Sponsors and collaborators

Lead sponsor

Theravance Biopharma

Industry

Registry information

Official study title

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-1439 in Healthy Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 16, 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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