Overview

This trial is active, not recruiting.

Condition healthy adults, elderly subjects
Treatments td-0714, placebo
Phase phase 1
Sponsor Theravance Biopharma R & D, Inc.
Start date March 2016
End date November 2016
Trial size 50 participants
Trial identifier NCT02709928, 0142

Summary

Multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy adult and elderly subjects

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Experimental)
Capsule formulation
td-0714
(Placebo Comparator)
Capsule formulation
placebo

Primary Outcomes

Measure
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

Measure
Pharmacokinetics (PK) of TD-0714 in plasma after multiple doses - peak plasma concentration (Cmax)
time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - time to peak plasma concentration (Tmax)
time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - time to last measurable concentration (Tlast)
time frame: 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 the last quantifiable concentration (AUC0-t)
time frame: 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)
time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - CL/F (oral plasma clearance)
time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)
time frame: Day 1 through Day 17
PK of TD-0714 in plasma after multiple doses - t1/2 (half-life)
time frame: Day 1 through Day 17
PK of TD-0714 in urine after multiple doses - Ae (amount excreted in urine)
time frame: Day 1 through Day 17
PK of TD-0714 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)
time frame: Day 1 through Day 17
PK of TD-0714 in urine after multiple doses - Clr (renal clearance)
time frame: Day 1 through Day 17
Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations
time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)
Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations
time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)
Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations
time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)
Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations
time frame: The day before dosing (Day -1) to 3 days after last dose (Day 17)

Eligibility Criteria

Male or female participants from 19 years up to 80 years old.

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

Additional Information

Official title 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
Principal investigator Michael Gartner, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Theravance Biopharma R & D, Inc..