Clinical trial NCT04551586: A Study to Assess ACH-0145228 When Administered as Immediate Release Tablet Versus Powder-In-Capsule in Healthy Adult Participants
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Factor D Inhibitor
Complement
Bioavailability
Tablet
Capsule
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This will be a 3-sequence, 3-period crossover study in healthy adult participants.
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. No clinically significant history or presence of electrocardiogram findings at screening.
3. Non-sterile male participants must agree to abstinence or use a highly effective method of contraception.
4. Female participants must be of non-childbearing potential and need not employ a method of contraception.

Exclusion Criteria:

1. Clinically significant laboratory abnormalities.
2. 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.
3. 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.
4. History or presence of clinically significant seizures, head injury, or head trauma.
5. History of procedures that could alter absorption or excretion of orally administered drugs.
6. History of meningococcal infection, or a first-degree relative with a history of meningococcal infection.
7. A history of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs.
8. 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.
9. Is a female of childbearing potential.
10. 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.
11. 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.

Primary outcomes:
measure: Relative Bioavailability Of ACH-0145228 Immediate Release Tablet And Powder-In-Capsule
timeFrame: Up to 72 hours postdose
Secondary outcomes:
measure: 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
timeFrame: Up to 72 hours postdose
measure: AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions
timeFrame: Up to 72 hours postdose
measure: Number Of Participants With Treatment-emergent Adverse Events
timeFrame: Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Clinical Trial Site
state: Nebraska
Study officials:
References: