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

NCT04551586 | Completed Phase 1 FDA Drug

• 1 other identifier: ACH228-004
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Factor D Inhibitor; Complement; Bioavailability; Tablet; Capsule

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• 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

Study Arms (3)

Sequence 1

EXPERIMENTAL

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; Drug: ACH-0145228: Powder-in-capsule

Sequence 2

EXPERIMENTAL

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; Drug: ACH-0145228: Powder-in-capsule

Sequence 3

EXPERIMENTAL

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; Drug: ACH-0145228: Powder-in-capsule

Interventions

ACH-0145228: Immediate Release DRUG

ACH-0145228 (240 milligrams) will be administered orally on Day 1.

Also known as: ALXN2050

Sequence 1; Sequence 2; Sequence 3

ACH-0145228: Powder-in-capsule DRUG

ACH-0145228 (240 milligrams) will be administered orally on Day 1.

Also known as: ALXN2050

Sequence 1; Sequence 2; Sequence 3

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (1)

Clinical Trial Site

Lincoln, Nebraska, 68502, United States

Location

Study Design

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

Model Details: This will be a 3-sequence, 3-period crossover study in healthy adult participants.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: June 26, 2020
• Primary Completion: October 19, 2020
• Study Completion: October 19, 2020
• Last Updated: December 28, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)