Clinical trial NCT02657122: SAD and MAD Study to Evaluate Safety, Tolerability, and Pharmacokinetics (PK) of TD-1473 in Healthy Subjects
Official title: A Double-blinded, Randomized, Placebo-controlled, Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TD-1473 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Single ascending dose
SAD
multiple ascending dose
MAD
Phase 1
first-in-human
volunteers
TD-1473
Lead sponsor: Theravance Biopharma
Sponsor class: INDUSTRY
First posted: 2016-01-15
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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 exclusion criteria apply

Primary outcomes:
measure: 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
timeFrame: Day 1 through Day 8 (SAD) or 21 (MAD)
Secondary outcomes:
measure: Area under curve (AUC) in plasma, urine and feces
timeFrame: Day 1 through Day 4-6 (SAD)
measure: Cmax in plasma, urine and feces
timeFrame: Day 1 through Day 4-6 (SAD)
measure: Tmax in plasma, urine and feces
timeFrame: Day 1 through Day 4-6 (SAD)
measure: Terminal elimination half-life (t1/2) in plasma, urine and feces
timeFrame: Day 1 through Day 4-6 (SAD)
measure: Amount excreted in urine (Aeu)
timeFrame: Day 1 through Day 4-6 (SAD)
measure: Amount excreted in feces (Aef)
timeFrame: Day 1 through Day 4-6 (SAD)
measure: AUC in plasma, urine and feces
timeFrame: Day 1 through Day 17-19 (MAD)
measure: Cmax in plasma, urine and feces
timeFrame: Day 1 through Day 17-19 (MAD)
measure: Tmax in plasma, urine and feces
timeFrame: Day 1 through Day 17-19 (MAD)
measure: t1/2 in plasma, urine and feces
timeFrame: Day 1 through Day 17-19 (MAD)
measure: Aeu
timeFrame: Day 1 through Day 17-19 (MAD)
measure: Aef
timeFrame: Day 1 through Day 17-19 (MAD)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Theravance Biopharma
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Sandborn WJ, Nguyen DD, Beattie DT, Brassil P, Krey W, Woo J, Situ E, Sana R, Sandvik E, Pulido-Rios MT, Bhandari R, Leighton JA, Ganeshappa R, Boyle DL, Abhyankar B, Kleinschek MA, Graham RA, Panes J. Development of Gut-Selective Pan-Janus Kinase Inhibitor TD-1473 for Ulcerative Colitis: A Translational Medicine Programme. J Crohns Colitis. 2020 Sep 16;14(9):1202-1213. doi: 10.1093/ecco-jcc/jjaa049.