Healthy
Conditions
Keywords
Single ascending dose, SAD, multiple ascending dose, MAD, Phase 1, first-in-human, volunteers, TD-1473
Brief summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of single ascending doses and multiple ascending doses of the investigational drug TD-1473 compared to placebo in healthy subjects.
Interventions
DRUGTD-1473 for SAD
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
DRUGPlacebo for SAD
SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
DRUGTD-1473 for MAD
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
DRUGPlacebo for MAD
MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
Sponsors
Theravance Biopharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female 19 to 55 years old * Willing and able to give informed consent * Body Mass Index (BMI) 18 to 30 kg/m2 * Women of child bearing potential must have a negative pregnancy test and either abstain from sex or use a highly effective method of birth control * Additional inclusion criteria apply
Exclusion criteria
* Positive for hepatitis A, B, or C, HIV, or tuberculosis (TB) * Clinically significant abnormalities in baseline results of laboratory evaluations * 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 * Participated in another clinical trial of an investigational drug (or medical device) within 30 days prior to Screening (or within 60 days prior to Screening if investigational drug was a biologic), or is currently participating in another trial of an investigational drug (or medical device) * Use of prescription drugs or any chronic over the counter medications within 14 days prior to clinic admission or requires continuing use during study participation, with the exception of hormonal contraceptives or hormone replacement therapy. * Additional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of SAD and MAD of TD-1473 in healthy subjects by assessing the number, severity and type of adverse events, including changes in vital signs, physical examinations, laboratory safety tests and ECGs | Day 1 through Day 8 (SAD) or 21 (MAD) |
Secondary
| Measure | Time frame |
|---|---|
| Cmax in plasma, urine and feces | Day 1 through Day 4-6 (SAD) |
| Tmax in plasma, urine and feces | Day 1 through Day 4-6 (SAD) |
| Terminal elimination half-life (t1/2) in plasma, urine and feces | Day 1 through Day 4-6 (SAD) |
| Amount excreted in urine (Aeu) | Day 1 through Day 4-6 (SAD) |
| Area under curve (AUC) in plasma, urine and feces | Day 1 through Day 4-6 (SAD) |
| AUC in plasma, urine and feces | Day 1 through Day 17-19 (MAD) |
| t1/2 in plasma, urine and feces | Day 1 through Day 17-19 (MAD) |
| Aeu | Day 1 through Day 17-19 (MAD) |
| Aef | Day 1 through Day 17-19 (MAD) |
| Amount excreted in feces (Aef) | Day 1 through Day 4-6 (SAD) |
Countries
United States
Outcome results
None listed