Multiple Ascending Dose Study of TD-0714 in Healthy and Elderly Subjects

Sponsor

Theravance Biopharma (Industry)

Overall Status

Completed

CT.gov ID

NCT02709928

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Adults, Elderly Subjects	Drug: TD-0714 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 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, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-0714 in Healthy Adult and Elderly Subjects

Study Start Date :

Mar 1, 2016

Actual Primary Completion Date :

Nov 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TD-0714 Capsule formulation	Drug: TD-0714
Placebo Comparator: Placebo Capsule formulation	Drug: Placebo

Arm

Intervention/Treatment

Experimental: TD-0714

Capsule formulation

Drug: TD-0714

Placebo Comparator: Placebo

Capsule formulation

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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 [From Day 1 through end of study (Day 25)]

Secondary Outcome Measures

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 peak plasma concentration (Tmax) [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 - 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 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 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]
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 urine after multiple doses - Clr (renal clearance) [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)]
Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations [The day before dosing (Day -1) to 3 days after last dose (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 cyclic guanosine monophosphate (cGMP) concentrations [The day before dosing (Day -1) to 3 days after last dose (Day 17)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 80 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:

NCT02709928

Other Study ID Numbers:

0142

First Posted:

Mar 16, 2016

Last Update Posted:

Jan 19, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Theravance Biopharma

Multiple ascending dose

Study Results

No Results Posted as of Jan 19, 2021