Single Ascending Dose Study of TD-0714 in Healthy Subjects
- Registration Number
- NCT02639078
- Lead Sponsor
- Theravance Biopharma
- Brief Summary
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Comparator Placebo comparator one time dosing in capsule formulation TD-0714 TD-0714 One time dosing in capsule formulation
- Primary Outcome Measures
Name Time Method Safety and tolerability of TD-0714 by assessing the number, severity and type of adverse events, including changes in vital signs, physical and neurological examinations, laboratory safety tests and ECGs From Day 1 through end of study (Day 10)
- Secondary Outcome Measures
Name Time Method PK of TD-0714 in plasma after a SD: t1/2 (half-life) Day 1 through end of study (Day 10) Pharmacokinetics (PK) of TD-0714 in plasma after a single-dose (SD): peak plasma concentration (Cmax) Day 1 through end of study (Day 10) PK of TD-0714 in plasma after a SD: Vz/F (apparent volume of distribution during the terminal phase) Day 1 through end of study (Day 10) PK of TD-0714 in urine after a SD: Ae (amount excreted in urine) Day 1 through end of study (Day 10) PK of TD-0714 in plasma after a SD: time to peak plasma concentration (Tmax) Day 1 through end of study (Day 10) PK of TD-0714 in plasma after a SD: time to last measurable concentration (Tlast) Day 1 through end of study (Day 10) PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to 24 hours postdose (AUC0-24) The day before dosing (Day -1) to the day after dosing (Day 2) PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to infinity (AUC0-∞) Day 1 through end of study (Day 10) PK of TD-0714 in plasma after a SD: CL/F (oral plasma clearance) Day 1 through end of study (Day 10) PK of TD-0714 in plasma after a SD: area under the plasma concentration vs. time curve from time zero to the last quantifiable concentration (AUC0-t) Day 1 through end of study (Day 10) PK of TD-0714 in urine after a SD: Clr (renal clearance) Day 1 through end of study (Day 10) PK of TD-0714 in urine after a SD: Fe (fraction of oral dose excreted in urine) Day 1 through end of study (Day 10)
Trial Locations
- Locations (1)
Celerion
🇺🇸Lincoln, Nebraska, United States