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Single Ascending Dose Study of TD-0714 in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT02639078
Recruitment Status : Completed
First Posted : December 24, 2015
Last Update Posted : March 7, 2016
Sponsor:
Information provided by (Responsible Party):
Theravance Biopharma

Brief Summary:
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.

Condition or disease Intervention/treatment Phase
Healthy Drug: TD-0714 Drug: Placebo Comparator Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : November 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Arm Intervention/treatment
Experimental: TD-0714
One time dosing in capsule formulation
Drug: TD-0714
One time dosing in capsule formulation

Placebo Comparator: Placebo
Placebo comparator one time dosing in capsule formulation
Drug: Placebo Comparator
One time dosing in capsule formulation




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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) ]


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:

  • 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

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): NCT02639078


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Theravance Biopharma
Investigators
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Principal Investigator: Michael Gartner, MD Celerion
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Responsible Party: Theravance Biopharma
ClinicalTrials.gov Identifier: NCT02639078    
Other Study ID Numbers: 0139
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Keywords provided by Theravance Biopharma:
Single ascending dose
volunteers
Phase 1
first-in-human
TD-0714