Bioavailability Study of 2 Oral Formulations of ALXN1840

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ALXN1840

Study type: Interventional

Funder types: Industry

Identifiers

NCT04610580

ALXN1840-HV-109

Details and patient eligibility

About

The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.

Full description

This is a two-way crossover study consisting of 2 dosing periods assessing a test and reference formulation of ALXN1840. A dose-proportionality parallel group design extension period will be conducted following completion of the two-way crossover period of the study and will assess 5 different ascending doses of ALXN1840. There will be at least a 14-day washout following doses between Periods 1 and 2 and also at least a 14-day washout following the dose in Period 2 and the following dose in the Dose-Proportionality Extension Period.

Safety will be assessed throughout the study.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• No clinically significant history or presence of electrocardiogram findings
• Body weight ≥50 to ≤100 kilograms (kg) and body mass index 18 to <32 kg/meter squared for all participants
• Willing and able to follow protocol-specified contraception requirements

Exclusion criteria

• History or presence of clinical and/or laboratory disorders
• Abnormal blood pressure, defined as supine blood pressure ≤90/60 millimeters of mercury (mmHg) or >140/90 mmHg
• Lymphoma, leukemia, or any malignancy within the past 5 years
• Alanine aminotransferase, aspartate aminotransferase, or total bilirubin > upper limit of normal
• Serum copper or serum ceruloplasmin below lower limit of normal
• Hemoglobin <130 grams (g)/liter (L) for males and hemoglobin <115 g/L for females
• Significant allergies
• Smoker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

48 participants in 6 patient groups

Crossover ALXN1840 Sequence 1

Experimental group

Description:

Participants will first receive a single dose of ALXN1840 test formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 reference formulation on Day 1 of Period 2.

Treatment:

Drug: ALXN1840

Crossover ALXN1840 Sequence 2

Experimental group

Description:

Participants will first receive a single dose of ALXN1840 reference formulation on Day 1 of Period 1. After a washout period of 14 days, they will then receive a single dose of ALXN1840 test formulation on Day 1 of Period 2.

Treatment:

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 1

Experimental group

Description:

Participants will receive a single dose of ALXN1840.

Treatment:

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 2

Experimental group

Description:

Participants will receive a single dose of ALXN1840.

Treatment:

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 3

Experimental group

Description:

Participants will receive a single dose of ALXN1840.

Treatment:

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 4

Experimental group

Description:

Participants will receive a single dose of ALXN1840.

Treatment:

Drug: ALXN1840