Celerion
Lincoln, Nebraska, 68502, United States
NCT Number: NCT02657122
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.
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Notify Me19 year–55 year
All sexes
Interventional
Phase 1
Lincoln, Nebraska, 68502, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
Time frame: Day 1 through Day 8 (SAD) or 21 (MAD)
Time frame: Day 1 through Day 4-6 (SAD)
Time frame: Day 1 through Day 4-6 (SAD)
Time frame: Day 1 through Day 4-6 (SAD)
Time frame: Day 1 through Day 4-6 (SAD)
Time frame: Day 1 through Day 4-6 (SAD)
Time frame: Day 1 through Day 4-6 (SAD)
Time frame: Day 1 through Day 17-19 (MAD)
Time frame: Day 1 through Day 17-19 (MAD)
Time frame: Day 1 through Day 17-19 (MAD)
Time frame: Day 1 through Day 17-19 (MAD)
Time frame: Day 1 through Day 17-19 (MAD)
Time frame: Day 1 through Day 17-19 (MAD)
Theravance Biopharma
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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