Single Ascending Dose Study of TD-1439 in Healthy Subjects

NCT02903095 | Completed Phase 1

• 1 other identifier: 0147
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Subjects

Keywords

Single ascending dose

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Pharmacokinetics (PK) of TD-1439 in plasma after multiple doses - peak plasma concentration (Cmax)

  Day 1 through Day 10

• PK of TD-1439 in plasma after multiple doses - time to peak plasma concentration (Tmax)

  Day 1 through Day 10

• PK of TD-1439 in plasma after multiple doses - time to last measurable concentration (Tlast)

  Day 1 through Day 10

• 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

• 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

Study Arms (2)

TD-1439

EXPERIMENTAL

Capsule formulation

Drug: TD-1439

Placebo

PLACEBO COMPARATOR

Capsule formulation

Drug: Placebo

Interventions

TD-1439 DRUG

TD-1439

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Theravance Biopharma: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Officials

• Medical Monitor

  Theravance Biopharma

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 16, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: January 19, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)