NCT02709928
Completed
Phase 1
A Phase 1, Double-blind, Randomized, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-0714 in Healthy Adult and Elderly Subjects
ConditionsHealthy Adults, Elderly Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Theravance Biopharma
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Safety of TD-0714 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Overview
Brief Summary
Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy adult and elderly 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 80 Years (Adult, Older 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
Capsule formulation
Intervention: TD-0714 (Drug)
Placebo
Placebo Comparator
Capsule formulation
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Safety of TD-0714 by assessing the number and severity of adverse events, including changes in vital signs, physical examination, laboratory safety tests, and ECGs
Time Frame: From Day 1 through end of study (Day 25)
Secondary Outcomes
- PK of TD-0714 in plasma after multiple doses - time to peak plasma concentration (Tmax)(Day 1 through Day 17)
- Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 17))
- PK of TD-0714 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t)(Day 1 through Day 17)
- PK of TD-0714 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)(Day 1 through Day 17)
- PK of TD-0714 in plasma after multiple doses - area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24)(Day 1 through Day 17)
- PK of TD-0714 in plasma after multiple doses - CL/F (oral plasma clearance)(Day 1 through Day 17)
- PK of TD-0714 in urine after multiple doses - Clr (renal clearance)(Day 1 through Day 17)
- Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 17))
- Pharmacokinetics (PK) of TD-0714 in plasma after multiple doses - peak plasma concentration (Cmax)(Day 1 through Day 17)
- PK of TD-0714 in plasma after multiple doses - time to last measurable concentration (Tlast)(Day 1 through Day 17)
- PK of TD-0714 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)(Day 1 through Day 17)
- PK of TD-0714 in plasma after multiple doses - t1/2 (half-life)(Day 1 through Day 17)
- PK of TD-0714 in urine after multiple doses - Ae (amount excreted in urine)(Day 1 through Day 17)
- Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 17))
- Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations(The day before dosing (Day -1) to 3 days after last dose (Day 17))
Investigators
Study Sites (1)
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