Single Ascending Dose Study of TD-1439 in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-1439 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02903095
• Other study ID #: 0147
• Status: Completed
• Phase: Phase 1
• Start date: September 2016
• Est. completion date: February 2017

Study information

• Verified date: January 2021
• Source: Theravance Biopharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-1439 in healthy subjects

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: February 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• TD-1439

• Placebo

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of TD-1439 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 10)
Secondary	Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)		Day 1 through Day 10
Secondary	PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)		Day 1 through Day 10
Secondary	PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)		Day 1 through Day 10
Secondary	PK of TD-1439 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 10
Secondary	PK of TD-1439 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 10
Secondary	PK of TD-1439 in plasma after multiple doses - CL/F (oral plasma clearance)		Day 1 through Day 10
Secondary	PK of TD-1439 in plasma after multiple doses - Vz/F (apparent volume of distribution during the terminal phase)		Day 1 through Day 10
Secondary	PK of TD-1439 in plasma after multiple doses - t1/2 (half-life)		Day 1 through Day 10
Secondary	PK of TD-1439 in urine after multiple doses - Ae (amount excreted in urine)		Day 1 through Day 10
Secondary	PK of TD-1439 in urine after multiple doses - Fe (fraction of oral dose excreted in urine)		Day 1 through Day 10
Secondary	PK of TD-1439 in urine after multiple doses - Clr (renal clearance)		Day 1 through Day 10
Secondary	Pharmacodynamic assessments for plasma atrial natriuretic peptide (ANP) concentrations		The day before dosing (Day -1) to 3 days after last dose (Day 4)
Secondary	Pharmacodynamic assessments for urine atrial natriuretic peptide (ANP) concentrations		The day before dosing (Day -1) to 3 days after last dose (Day 4)
Secondary	Pharmacodynamic assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations		The day before dosing (Day -1) to 3 days after last dose (Day 4)
Secondary	Pharmacodynamic assessments for urine cyclic guanosine monophosphate (cGMP) concentrations		The day before dosing (Day -1) to 3 days after last dose (Day 4)