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Clinical Trials/NCT02639078
NCT02639078
Completed
Phase 1

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

Theravance Biopharma1 site in 1 country56 target enrollmentStarted: November 2015Last updated:
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ConditionsHealthy
InterventionsTD-0714Placebo Comparator
DrugsTD-0714Placebo Comparator

Overview

Phase
Phase 1
Status
Completed
Enrollment
56
Locations
1
Primary Endpoint
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
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
19 Years to 55 Years (Adult)
Sex
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.

Arms & Interventions

TD-0714

Experimental

One time dosing in capsule formulation

Intervention: TD-0714 (Drug)

Placebo

Placebo Comparator

Placebo comparator one time dosing in capsule formulation

Intervention: Placebo Comparator (Drug)

Outcomes

Primary Outcomes

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

  • PK of TD-0714 in plasma after a SD: t1/2 (half-life)(Day 1 through end of study (Day 10))
  • 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: Vz/F (apparent volume of distribution during the terminal phase)(Day 1 through end of study (Day 10))
  • PK of TD-0714 in urine after a SD: Ae (amount excreted in urine)(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 24 hours postdose (AUC0-24)(The day before dosing (Day -1) to the day after dosing (Day 2))
  • 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))
  • PK of TD-0714 in plasma after a SD: CL/F (oral plasma clearance)(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 urine after a SD: Fe (fraction of oral dose excreted in urine)(Day 1 through end of study (Day 10))
  • PK of TD-0714 in urine after a SD: Clr (renal clearance)(Day 1 through end of study (Day 10))

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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