PRA Health Sciences
Lenexa, Kansas, 66219, United States
NCT Number: NCT03101293
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Lenexa, Kansas, 66219, United States
The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants under fasting and fed conditions in order to determine the effect of food on the PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
TAK-831 film-coated tablet.
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Time frame: Day 1
Neurocrine Biosciences
Industry
A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Design, Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 T2 Tablet Formulation 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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