NCT02639078

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

November 25, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

December 24, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

October 13, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

November 25, 2015

Last Update Submit

October 5, 2021

Conditions

Healthy

Keywords

Single ascending dosevolunteersPhase 1first-in-humanTD-0714

Outcome Measures

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

    From Day 1 through end of study (Day 10)

Secondary Outcomes (12)

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

    Day 1 through end of study (Day 10)

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

    Day 1 through end of study (Day 10)

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

    Day 1 through end of study (Day 10)

  • 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)

  • 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)

  • +7 more secondary outcomes

Other Outcomes (4)

  • Pharmacodynamics assessments for plasma atrial natriuretic peptide (ANP) concentrations

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

  • Pharmacodynamics assessments for urine atrial natriuretic peptide (ANP) concentrations

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

  • Pharmacodynamics assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations

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

  • +1 more other outcomes

Study Arms (2)

TD-0714

EXPERIMENTAL

One time dosing in capsule formulation

Drug: TD-0714

Placebo

PLACEBO COMPARATOR

Placebo comparator one time dosing in capsule formulation

Drug: Placebo Comparator

Interventions

TD-0714DRUG

One time dosing in capsule formulation

TD-0714
Placebo ComparatorDRUG

One time dosing in capsule formulation

Placebo

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

  • Medical Monitor

    Theravance Biopharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2015

First Posted

December 24, 2015

Study Start

November 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

October 13, 2021

Record last verified: 2021-10

Locations

US(1)