NCT05578846

Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and Food Effect on ALXN2050 Pharmacokinetics

A Phase 1 Study to Assess the Bioequivalence Between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics in Healthy Adult Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Alexion Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the Bioequivalence between 180 mg and 60 mg ALXN2050 Tablets and the Effect of Food on ALXN2050 Pharmacokinetics.

Detailed description

This is a single-center, open-label, randomized, 3-period crossover study. Screening of participants will occur within 28 days prior to the first dose of study intervention. The study will comprise of 3 Treatment Periods: Treatment period 1, Treatment period 2, Treatment period 3. There will be a washout period of at least 4 days between the ALXN2050 dose in each treatment period. Participants will be enrolled and will be randomized 1:1:1:1:1:1 to receive one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA). On the morning of Day 1 of each of the 3 periods, participants will receive one of the following treatments as per the randomization scheme. * Treatment A: Dose B of ALXN2050 tablet under fasted conditions * Treatment B: A single Dose A dose of ALXN2050 tablet under fasted conditions * Treatment C: A single Dose A dose of ALXN2050 tablet with a high-fat meal Duration of study conduct (screening to follow-up): approximately 47 days.

Conditions

• Healthy Adult Participants

Interventions

Type	Name	Description
DRUG	Treatment A	Participants will receive single Dose A dose of ALXN2050 tablet (3 × Dose B) orally under fasted conditions.
DRUG	Treatment B	Participant will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally under fasted conditions.
DRUG	Treatment C	Participants will receive single Dose A of ALXN2050 tablet (1 × Dose A) orally with a high-fat meal.

Timeline

• Start date: 2022-10-13
• Primary completion: 2023-01-05
• Completion: 2023-01-05
• First posted: 2022-10-13
• Last updated: 2025-02-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study