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Completed

NCT Number: NCT02639078

Single Ascending Dose Study of TD-0714 in Healthy Subjects

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 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-0714

Drug

One time dosing in capsule formulation

placebo comparator

Drug

One time dosing in capsule formulation

Primary outcomes

  1. Safety and tolerability of TD-0714 by assessing the number, severity and type of adverse events, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs

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

Secondary outcomes

  1. Pharmacokinetics (PK) of TD-0714 in plasma after a single-dose (SD): peak plasma concentration (Cmax)

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

  2. PK of TD-0714 in plasma after a SD: time to peak plasma concentration (Tmax)

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

  3. PK of TD-0714 in plasma after a SD: time to last measurable concentration (Tlast)

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

  4. PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)

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

  5. PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)

    Time frame: The day before dosing (Day -1) to the day after dosing (Day 2)

  6. PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to infinity (AUC0-∞)

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

  7. PK of TD-0714 in plasma after a SD: CL/F (oral plasma clearance)

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

  8. PK of TD-0714 in plasma after a SD: Vz/F (apparent volume of distribution during the terminal phase)

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

  9. PK of TD-0714 in plasma after a SD: t1/2 (half-life)

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

  10. PK of TD-0714 in urine after a SD: Ae (amount excreted in urine)

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

  11. PK of TD-0714 in urine after a SD: Fe (fraction of oral dose excreted in urine)

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

  12. PK of TD-0714 in urine after a SD: Clr (renal clearance)

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

Other outcomes

  1. Pharmacodynamics assessments for plasma atrial natriuretic peptide (ANP) concentrations

    Time frame: The day before dosing (Day -1) to the day after dosing (Day 2)

  2. Pharmacodynamics assessments for urine atrial natriuretic peptide (ANP) concentrations

    Time frame: The day before dosing (Day -1) to the day after dosing (Day 2)

  3. Pharmacodynamics assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations

    Time frame: The day before dosing (Day -1) to the day after dosing (Day 2)

  4. Pharmacodynamics assessments for urine cyclic guanosine monophosphate (cGMP) concentrations

    Time frame: The day before dosing (Day -1) to the day after dosing (Day 2)

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-0714 in Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 24, 2015
Registry last updated
Oct 13, 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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