Bioavailability Study of 2 Oral Formulations of ALXN1840

NCT04610580 | Completed Phase 1 Results FDA Drug

• 1 other identifier: ALXN1840-HV-109
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Bioavailability; Healthy

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (5)

• Dose-Proportionality Extension Period: Cmax For Plasma Total Mo

  predose (0.5 hour) and up to 336 hours postdose

• Dose-Proportionality Extension Period: Cmax For Plasma PUF Mo

  predose (0.5 hour) and up to 336 hours postdose

• Dose-Proportionality Extension Period: AUCt For Plasma Total Mo

  predose (0.5 hour) and up to 336 hours postdose

• Dose-Proportionality Extension Period: AUCt For Plasma PUF Mo

  predose (0.5 hour) and up to 336 hours postdose

• Dose-Proportionality Extension Period: AUCinf For Plasma Total Mo

  predose (0.5 hour) and up to 336 hours postdose

Study Arms (6)

Crossover ALXN1840 Sequence 1

EXPERIMENTAL

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.

Drug: ALXN1840

Crossover ALXN1840 Sequence 2

EXPERIMENTAL

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.

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 1

EXPERIMENTAL

Participants will receive a single dose of ALXN1840.

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 2

EXPERIMENTAL

Participants will receive a single dose of ALXN1840.

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 3

EXPERIMENTAL

Participants will receive a single dose of ALXN1840.

Drug: ALXN1840

Parallel Dose-proportionality Extension: ALXN1840 Dose 4

EXPERIMENTAL

Participants will receive a single dose of ALXN1840.

Drug: ALXN1840

Interventions

ALXN1840 DRUG

ALXN1840 will be administered orally.

Also known as: Tiomolibdate choline, Tiomolibdic acid

Crossover ALXN1840 Sequence 1; Crossover ALXN1840 Sequence 2; Parallel Dose-proportionality Extension: ALXN1840 Dose 1; Parallel Dose-proportionality Extension: ALXN1840 Dose 2; Parallel Dose-proportionality Extension: ALXN1840 Dose 3; Parallel Dose-proportionality Extension: ALXN1840 Dose 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Nucleus Network Pty Ltd.

Melbourne, Victoria, 3004, Australia

Location

Results Point of Contact

• Title: Alexion Pharmaceuticals Inc.
• Organization: Alexion Pharmaceuticals Inc.

clinicaltrials@alexion.com

+1 855-752-2356

Study Officials

• Eugene S. Swenson, MD, PhD

  Alexion Pharmaceuticals, Inc.

  STUDY DIRECTOR

• Masood Sadaat, MD, MSc

  Alexion Pharmaceuticals, Inc.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a 2-period, 2-sequence, crossover study with a parallel group extension.

Study Record Dates

• First Submitted: October 13, 2020
• First Posted: October 30, 2020
• Study Start: January 31, 2021
• Primary Completion: March 24, 2021
• Study Completion: April 26, 2021
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)