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

Alexion Pharmaceuticals, Inc.1 site in 1 country28 target enrollmentJune 26, 2020

ConditionsHealthy

DrugsACH-0145228: Immediate Release ACH-0145228: Powder-in-capsule

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Healthy
Sponsor: Alexion Pharmaceuticals, Inc.
Enrollment: 28
Locations: 1
Primary Endpoint: Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 26, 2020

End Date

October 19, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Alexion Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

Outcomes

Primary Outcomes

Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule

Time Frame: Up to 72 hours postdose

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).

Secondary Outcomes

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)
Cmax Of ACH-0145228 Powder-in-capsule Under 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)
AUC0-inf Of ACH-0145228 Powder-in-capsule Under 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)
Tmax Of ACH-0145228 Powder-in-capsule Under 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)
Number Of Participants With Treatment-emergent Adverse Events(Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration))