Clinical Study Site
Tempe, Arizona, 85283, United States
NCT Number: NCT04709081
This was a 2-part study (Part 1 and Part 2), with each part being an open-label, fixed sequence, 2-period study in healthy adult participants.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Tempe, Arizona, 85283, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
Other names: ALXN2050
Midazolam was dosed at 2 mg (1 milliliter [mL] of a 2 mg/mL syrup).
Other names: Midazolam HCl
Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
Other names: Lanoxin
Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).
Other names: Sporanox
Time frame: Up to 24 hours postdose
Time frame: Up to 24 hours postdose
Time frame: Up to 24 hours postdose
Time frame: Up to 168 hours postdose
Time frame: Up to 168 hours postdose
Time frame: Up to 168 hours postdose
Time frame: Up to 96 hours postdose
Time frame: Up to 96 hours postdose
Time frame: Up to 96 hours postdose
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Time frame: Day 1 (postdose) through follow-up (14 [+/- 2] days after last study drug administration)
Alexion Pharmaceuticals, Inc.
Industry
A Two-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0145228 and Midazolam, Digoxin, and Itraconazole in Healthy Adult 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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