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Completed

NCT Number: NCT04551586

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ACH-0145228: Immediate Release

Drug

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

Other names: ALXN2050

ACH-0145228: Powder-in-capsule

Drug

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

Other names: ALXN2050

Primary outcomes

  1. 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

  1. 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

    Time frame: Up to 72 hours postdose

  2. AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  3. Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  4. Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions

    Time frame: Up to 72 hours postdose

  5. AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions

    Time frame: Up to 72 hours postdose

  6. AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions

    Time frame: Up to 72 hours postdose

  7. Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions

    Time frame: Up to 72 hours postdose

  8. Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions

    Time frame: Up to 72 hours postdose

  9. Number Of Participants With Treatment-emergent Adverse Events

    Time frame: Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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