Single Ascending Dose Study of TD-0714 in Healthy Subjects

Sponsor
Theravance Biopharma (Industry)
Overall Status
Completed
CT.gov ID
NCT02639078
Collaborator
(none)
56
1
2
3
18.5

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
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 :
Nov 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Feb 1, 2016

Arms and Interventions

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

Outcome Measures

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 [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) [Day 1 through end of study (Day 10)]

  2. PK of TD-0714 in plasma after a SD: time to peak plasma concentration (Tmax) [Day 1 through end of study (Day 10)]

  3. PK of TD-0714 in plasma after a SD: time to last measurable concentration (Tlast) [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) [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) [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-∞) [Day 1 through end of study (Day 10)]

  7. PK of TD-0714 in plasma after a SD: CL/F (oral plasma clearance) [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) [Day 1 through end of study (Day 10)]

  9. PK of TD-0714 in plasma after a SD: t1/2 (half-life) [Day 1 through end of study (Day 10)]

  10. PK of TD-0714 in urine after a SD: Ae (amount excreted in urine) [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) [Day 1 through end of study (Day 10)]

  12. PK of TD-0714 in urine after a SD: Clr (renal clearance) [Day 1 through end of study (Day 10)]

Other Outcome Measures

  1. Pharmacodynamics assessments for plasma atrial natriuretic peptide (ANP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]

  2. Pharmacodynamics assessments for urine atrial natriuretic peptide (ANP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]

  3. Pharmacodynamics assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]

  4. Pharmacodynamics assessments for urine cyclic guanosine monophosphate (cGMP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celerion Lincoln Nebraska United States 68502

Sponsors and Collaborators

  • Theravance Biopharma

Investigators

  • Study Director: Medical Monitor, Theravance Biopharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Theravance Biopharma
ClinicalTrials.gov Identifier:
NCT02639078
Other Study ID Numbers:
  • 0139
First Posted:
Dec 24, 2015
Last Update Posted:
Oct 13, 2021
Last Verified:
Oct 1, 2021
Keywords provided by Theravance Biopharma

Study Results

No Results Posted as of Oct 13, 2021