Bioavailability Study of 2 Oral Formulations of ALXN1840

Healthy Clinical Trial

Official title:

A Phase 1, Randomized, 2-period, 2-sequence, Crossover With Parallel-group Extension, Open-label Study to Compare the Relative Bioavailability of 2 Oral Formulations of ALXN1840 in Healthy Adult Participants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04610580
• Other study ID #: ALXN1840-HV-109
• Status: Completed
• Phase: Phase 1
• Start date: January 31, 2021
• Est. completion date: April 26, 2021

Study information

• Verified date: April 2023
• Source: Alexion Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: April 26, 2021
• Est. primary completion date: March 24, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ALXN1840
ALXN1840 will be administered orally.

Locations

Country	Name	City	State
Australia	Nucleus Network Pty Ltd.	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals, Inc.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Two-way Crossover Period: Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo)	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via inductively coupled plasma-mass spectroscopy (ICP-MS).	predose (0.5 hour) and up to 336 hours postdose
Primary	Two-way Crossover Period: Cmax for PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Primary	Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Primary	Two-way Crossover Period: AUCt for Plasma PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Primary	Two-way Crossover Period: Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Secondary	Dose-Proportionality Extension Period: Cmax For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Secondary	Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Secondary	Dose-Proportionality Extension Period: AUCt For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Secondary	Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo	Whole blood samples were collected for the measurement of plasma concentrations of PUF Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose
Secondary	Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo	Whole blood samples were collected for the measurement of plasma concentrations of total Mo via ICP-MS.	predose (0.5 hour) and up to 336 hours postdose