Study of Different Forms of Danicopan (Tablet, Softgel Capsule, Liquid-filled Capsule) in Healthy Participants

Healthy Clinical Trial

Official title:

A Phase 1 Study To Determine The Relative Bioavailability Of ACH-0144471 After Administration Of A Tablet Or Softgel Capsule Versus A Liquid Filled Capsule In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04940559
• Other study ID #: ACH471-006
• Secondary ID: ACTRN12616001017
• Status: Completed
• Phase: Phase 1
• Start date: August 2, 2016
• Est. completion date: October 5, 2016

Study information

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

Clinical Trial Summary

This was a randomized, crossover, open-label study to assess the relative bioavailability, pharmacokinetics (PK), and safety of three different formulations of danicopan (tablet, softgel capsule, liquid-filled capsule [LFC]) in healthy participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 5, 2016
• Est. primary completion date: October 5, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and heart rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.

• Had a body mass index of 18 to 30 kilograms(kg)/meter squared with a minimum body weight of 50 kg.

Key Exclusion Criteria:

• History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.

• History of procedures that could alter absorption of orally administered drugs.

• Body temperature = 38°Celsius on Day -1 or Day 1 predose; history of febrile illness within 7 days prior to study drug administration.

• Positive alcohol and/or drug screen at Screening or Day -1; current tobacco/nicotine user.

• Participation in a clinical study within 30 days prior to study drug administration.

• Clinically significant laboratory abnormalities at Screening or Day -1.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Danicopan - Tablet
Oral tablet.
• Danicopan - Softgel
Oral softgel capsule.
• Danicopan - LFC
Oral LFC.

Locations

Country	Name	City	State
New Zealand	Clinical Trial Site	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations		Up to 96 hours postdose
Primary	PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations		Up to 96 hours postdose
Primary	PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations		Up to 96 hours postdose
Secondary	PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions		Up to 96 hours postdose
Secondary	PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions		Up to 96 hours postdose
Secondary	PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions		Up to 96 hours postdose
Secondary	Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation		Day 1 through Day 39