Clinical Study Site
Brisbane, Australia
NCT Number: NCT04451434
This study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of danicopan after a single-dose oral administration under fed and fasting conditions to participants of Japanese descent.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Brisbane, Australia
This will be an open-label, randomized, single-dose, 3-period, 3-treatment crossover study in participants of Japanese descent.
On Day 1 of each period, participants will receive a single oral dose of 200 milligrams (mg) danicopan under fasting conditions, 200 mg danicopan under fed conditions, or 400 mg danicopan under fed conditions. Participants will receive each treatment once, according to the randomization schedule. There will be a washout period of at least 7 days between each dose of study intervention.
Safety will be assessed throughout the study.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral tablet
Other names: ALXN2040, ACH-0144471
Time frame: Day 1 (after first dose) through safety follow-up (10 +/- 2 days after last dose)
Time frame: up to 72 hours postdose
Time frame: up to 72 hours postdose
Time frame: up to 72 hours postdose
Time frame: up to 72 hours postdose
Time frame: up to 72 hours postdose
Time frame: up to 72 hours postdose
Blood samples will be collected for measurement of danicopan activity.
Time frame: up to 72 hours postdose
Blood samples will be collected for measurement of complement factor B fraction b levels.
Alexion Pharmaceuticals, Inc.
Industry
A Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of Danicopan After Administration as an Oral Tablet in the Fed and Fasted States in Participants of Japanese Descent
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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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