Single Ascending Dose Study of TD-0714 in Healthy Subjects

Study Overview
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Brief Summary
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Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.

Official Title
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A Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TD-0714 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: TD-0714
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-0714<br>One time dosing in capsule formulation | Drug: TD-0714<br>* One time dosing in capsule formulation<br>|
| Placebo Comparator: Placebo<br>Placebo comparator one time dosing in capsule formulation | Drug: Placebo Comparator<br>* One time dosing in capsule formulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: 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 the last quantifiable concentration (AUC0-t) |  | 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: Vz/F (apparent volume of distribution during the terminal phase) |  | Day 1 through end of study (Day 10) | 
| PK of TD-0714 in plasma after a SD: t1/2 (half-life) |  | 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 urine after a SD: Fe (fraction of oral dose excreted in urine) |  | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Single ascending dose, volunteers, Phase 1, first-in-human, TD-0714