A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants

Study Overview
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Brief Summary
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This will be an open-label, 3-sequence, 3-period crossover study in healthy adult participants to assess the relative bioavailability of ACH-0145228 when administered as an immediate release tablet versus powder-in-capsule.

Official Title
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A Phase 1 Study to Assess the Relative Bioavailability of ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: ACH-0145228: Immediate Release
* Drug: ACH-0145228: Powder-in-capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index in the range of 18.0 to 32.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at screening. No clinically significant history or presence of electrocardiogram findings at screening. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception. Female participants must be of non-childbearing potential and need not employ a method of contraception. Exclusion Criteria: Clinically significant laboratory abnormalities. History of any medical or psychiatric condition or disease that might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study. History or presence of drug or alcohol abuse within previous 2 years, current tobacco user, and positive drugs-of-abuse screen and alcohol screen at screening or Day -1 of Period 1. History or presence of clinically significant seizures, head injury, or head trauma. History of procedures that could alter absorption or excretion of orally administered drugs. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs. Body temperature ≥ 38.0°Celsius at screening or prior to first dosing in Period 1 or history of febrile illness, or other evidence of infection, within 14 days prior to (first) dosing. Is a female of childbearing potential. Donation of whole blood from 3 months prior to first dosing, or of plasma from 30 days before first dosing, and receipt of blood products within 6 months prior to first dosing. Participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 5 half-lives (if known) or 30 days before first dosing, whichever is longer.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This will be a 3-sequence, 3-period crossover study in healthy adult participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 2: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 3: ACH-0145228 as power-in-capsule under fasted conditions (reference). There will be a washout period of at least 5 days between each ACH-0145228 dosing. | Drug: ACH-0145228: Immediate Release<br>* ACH-0145228 (240 milligrams) will be administered orally on Day 1.<br>* Other names: ALXN2050;Drug: ACH-0145228: Powder-in-capsule<br>* ACH-0145228 (240 milligrams) will be administered orally on Day 1.<br>* Other names: ALXN2050;|
| Experimental: Sequence 2<br>Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). Period 2: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 3: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). There will be a washout period of at least 5 days between each ACH-0145228 dosing. | Drug: ACH-0145228: Immediate Release<br>* ACH-0145228 (240 milligrams) will be administered orally on Day 1.<br>* Other names: ALXN2050;Drug: ACH-0145228: Powder-in-capsule<br>* ACH-0145228 (240 milligrams) will be administered orally on Day 1.<br>* Other names: ALXN2050;|
| Experimental: Sequence 3<br>Participants will receive ACH-0145228 once each Period as a single dose under fasted or fed conditions as follows: Period 1: ACH-0145228 as power-in-capsule under fasted conditions (reference). Period 2: ACH-0145228 as an immediate-release tablet under fasted conditions (test-fasted). Period 3: ACH-0145228 as an immediate-release tablet under fed conditions (test-fed). There will be a washout period of at least 5 days between each ACH-0145228 dosing. | Drug: ACH-0145228: Immediate Release<br>* ACH-0145228 (240 milligrams) will be administered orally on Day 1.<br>* Other names: ALXN2050;Drug: ACH-0145228: Powder-in-capsule<br>* ACH-0145228 (240 milligrams) will be administered orally on Day 1.<br>* Other names: ALXN2050;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule | Relative bioavailability will be measured by the ratio of the area under the concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf). | Up to 72 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under The Concentration Versus Time Curve From Time 0 To The Last Measurable Concentration (AUC0-t) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions |  | Up to 72 hours postdose | 
| AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions |  | Up to 72 hours postdose | 
| Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions |  | Up to 72 hours postdose | 
| Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions |  | Up to 72 hours postdose | 
| AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions |  | Up to 72 hours postdose | 
| AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions |  | Up to 72 hours postdose | 
| Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions |  | Up to 72 hours postdose | 
| Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions |  | Up to 72 hours postdose | 
| Number Of Participants With Treatment-emergent Adverse Events |  | Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Factor D Inhibitor, Complement, Bioavailability, Tablet, Capsule