NCT04709081

A Drug Interaction Study of ACH-0145228

A Two-Part Phase 1 Study to Evaluate the Potential Drug Interaction Between ACH-0145228 and Midazolam, Digoxin, and Itraconazole in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	ACH-0145228	ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
DRUG	Midazolam	Midazolam was dosed at 2 mg (1 milliliter \[mL\] of a 2 mg/mL syrup).
DRUG	Digoxin	Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
DRUG	Itraconazole	Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).

Timeline

• Start date: 2019-12-22
• Primary completion: 2020-04-16
• Completion: 2020-04-16
• First posted: 2021-01-14
• Last updated: 2021-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study