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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551586
• Other study ID #: ACH228-004
• Status: Completed
• Phase: Phase 1
• Start date: June 26, 2020
• Est. completion date: October 19, 2020

Study information

• Verified date: November 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 19, 2020
• Est. primary completion date: October 19, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• ACH-0145228: Immediate Release
ACH-0145228 (240 milligrams) will be administered orally on Day 1.
• ACH-0145228: Powder-in-capsule
ACH-0145228 (240 milligrams) will be administered orally on Day 1.

Locations

Country	Name	City	State
United States	Clinical Trial Site	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	AUC0-inf Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Secondary	Maximum Observed Concentration (Cmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Secondary	Time To Maximum Observed Concentration (Tmax) Of ACH-0145228 Immediate-release Tablet Under Both Fed And Fasted Conditions		Up to 72 hours postdose
Secondary	AUC0-t Of ACH-0145228 Powder-in-capsule Under Fasted Conditions		Up to 72 hours postdose
Secondary	AUC0-inf Of ACH-0145228 Powder-in-capsule Under Fasted Conditions		Up to 72 hours postdose
Secondary	Cmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions		Up to 72 hours postdose
Secondary	Tmax Of ACH-0145228 Powder-in-capsule Under Fasted Conditions		Up to 72 hours postdose
Secondary	Number Of Participants With Treatment-emergent Adverse Events		Day 1 (postdose) through follow-up (30 [+/- 2] days after last study drug administration)