Single Ascending Dose Study of TD-0714 in Healthy Subjects
Study Details
Study Description
Brief Summary
Single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TD-0714 in healthy subjects.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: TD-0714 One time dosing in capsule formulation |
Drug: TD-0714
One time dosing in capsule formulation
|
Placebo Comparator: Placebo Placebo comparator one time dosing in capsule formulation |
Drug: Placebo Comparator
One time dosing in capsule formulation
|
Outcome Measures
Primary Outcome Measures
- 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
- 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)]
Other Outcome Measures
- Pharmacodynamics assessments for plasma atrial natriuretic peptide (ANP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]
- Pharmacodynamics assessments for urine atrial natriuretic peptide (ANP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]
- Pharmacodynamics assessments for plasma cyclic guanosine monophosphate (cGMP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]
- Pharmacodynamics assessments for urine cyclic guanosine monophosphate (cGMP) concentrations [The day before dosing (Day -1) to the day after dosing (Day 2)]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Body Mass Index (BMI) 18 to 32 kg/m2 inclusive
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Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use highly effective methods of birth control
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Women of non-childbearing potential are at least 2 years postmenopausal or are surgically sterile
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Males must abstain from sex or use highly effective methods of birth control
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Negative for HIV, and Hepatitis A, B, and C
Exclusion Criteria:
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Female subjects who are pregnant, lactating, breastfeeding or planning to become pregnant during the study.
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Subjects with a history of angioedema.
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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.
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Subject has acute illness (gastrointestinal, infection [e.g., influenza] or known inflammatory process)
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Subject bradycardia
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Subject has hypertension
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Subjects has orthostatic hypotension
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Subjects has orthostatic tachycardia
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Subject has a known personal or family history of congenital long QT syndrome or known family history of sudden death.
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Subject has donated blood or blood components or has had blood loss exceeding 400 mL within the 90 days prior to Screening.
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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.- 0139