Bioavailability Study of 2 Oral Formulations of ALXN1840

Study Overview
=================
Brief Summary
-----------------
The study will assess the relative bioavailability of 2 different formulations of ALXN1840 in healthy participants.

Detailed 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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: ALXN1840


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This is a 2-period, 2-sequence, crossover study with a parallel group extension.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crossover ALXN1840 Sequence 1<br>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<br>* ALXN1840 will be administered orally.<br>* Other names: Tiomolibdic acid;|
| Experimental: Crossover ALXN1840 Sequence 2<br>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<br>* ALXN1840 will be administered orally.<br>* Other names: Tiomolibdic acid;|
| Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 1<br>Participants will receive a single dose of ALXN1840. | Drug: ALXN1840<br>* ALXN1840 will be administered orally.<br>* Other names: Tiomolibdic acid;|
| Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 2<br>Participants will receive a single dose of ALXN1840. | Drug: ALXN1840<br>* ALXN1840 will be administered orally.<br>* Other names: Tiomolibdic acid;|
| Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 3<br>Participants will receive a single dose of ALXN1840. | Drug: ALXN1840<br>* ALXN1840 will be administered orally.<br>* Other names: Tiomolibdic acid;|
| Experimental: Parallel Dose-proportionality Extension: ALXN1840 Dose 4<br>Participants will receive a single dose of ALXN1840. | Drug: ALXN1840<br>* ALXN1840 will be administered orally.<br>* Other names: Tiomolibdic acid;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Bioavailability Of ALXN1840 Test And Reference Formulations As Assessed By Maximum Observed Concentration (Cmax) For Plasma Total Molybdenum (Mo) and Plasma Ultrafiltrate (PUF) Mo |  | Period 1: up to 336 hours postdose and Period 2: up to 336 hours postdose | 
| Relative Bioavailability Of ALXN1840 Test And Reference Formulations As Assessed By Area Under The Plasma Concentration Versus Time Curve From Time 0 To The Last Quantifiable Concentration (AUCt) For Plasma Total Mo and PUF Mo |  | Period 1: up to 336 hours postdose and Period 2: up to 336 hours postdose | 
| Relative Bioavailability Of ALXN1840 Test And Reference Formulations As Assessed By Area Under The Plasma Concentration Versus Time Curve From Time 0 To Infinity (AUCinf) For Plasma Total Mo and PUF Mo |  | Period 1: up to 336 hours postdose and Period 2: up to 336 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extension Period: Dose-proportionality Between 4 Ascending Doses Of ALXN1840 As Assessed by Dose-normalized Cmax For Plasma Total Mo and PUF Mo |  | up to 336 hours postdose | 
| Extension Period: Dose-proportionality Between 4 Ascending Doses Of ALXN1840 As Assessed by Dose-normalized AUCt For Plasma Total Mo and PUF Mo |  | up to 336 hours postdose | 
| Extension Period: Dose-proportionality Between 4 Ascending Doses Of ALXN1840 As Assessed by Dose-normalized AUCinf For Plasma Total Mo and PUF Mo |  | up to 336 hours postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bioavailability, Healthy