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

June 21, 2021 updated by: Alexion Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
      • Auckland, New Zealand
        • Clinical Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1: Sequence 1

Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:

Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 3: Danicopan as a tablet under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Drug: Danicopan - Tablet
Oral tablet.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
Drug: Danicopan - LFC
Oral LFC.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
EXPERIMENTAL: Group 1: Sequence 2

Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:

Period 1: Danicopan as a tablet under fed (medium-fat meal) conditions. Period 2: Danicopan as a tablet under fasted conditions. Period 3: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Drug: Danicopan - Tablet
Oral tablet.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
Drug: Danicopan - LFC
Oral LFC.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
EXPERIMENTAL: Group 1: Sequence 3

Participants received danicopan once each period as a single dose under fasted or fed (medium-fat meal) conditions as follows:

Period 1: Danicopan as a tablet under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. Period 3: Danicopan as a tablet under fed (medium-fat meal) conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Drug: Danicopan - Tablet
Oral tablet.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
Drug: Danicopan - LFC
Oral LFC.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
EXPERIMENTAL: Group 2: Sequence 1

Participants received danicopan once each period as a single dose under fasted conditions as follows:

Period 1: Danicopan as an LFC under fasted conditions. Period 2: Danicopan as a softgel capsule under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Drug: Danicopan - LFC
Oral LFC.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
Drug: Danicopan - Softgel
Oral softgel capsule.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
EXPERIMENTAL: Group 2: Sequence 2

Participants received danicopan once each period as a single dose under fasted conditions as follows:

Period 1: Danicopan as a softgel capsule under fasted conditions. Period 2: Danicopan as an LFC under fasted conditions. There was a washout period of at least 4 days (96 hours) between each danicopan dosing.
Drug: Danicopan - LFC
Oral LFC.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471
Drug: Danicopan - Softgel
Oral softgel capsule.
Other Names:
  • ALXN2040
  • ACH-0144471 (formerly)
  • ACH-4471
  • ACH4471
  • 4471

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations
Time Frame: Up to 96 hours postdose
Up to 96 hours postdose
PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations
Time Frame: Up to 96 hours postdose
Up to 96 hours postdose
PK: Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-Inf) Of Danicopan After Treatment With Each Of The Three Formulations
Time Frame: Up to 96 hours postdose
Up to 96 hours postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time Frame: Up to 96 hours postdose
Up to 96 hours postdose
PK: Tmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time Frame: Up to 96 hours postdose
Up to 96 hours postdose
PK: AUC0-inf Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions
Time Frame: Up to 96 hours postdose
Up to 96 hours postdose
Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation
Time Frame: Day 1 through Day 39
Day 1 through Day 39

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals

Collaborators

Achillion, a wholly owned subsidiary of Alexion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 2, 2016

Primary Completion (ACTUAL)

October 5, 2016

Study Completion (ACTUAL)

October 5, 2016

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (ACTUAL)

June 25, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2021

Last Update Submitted That Met QC Criteria

June 21, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ACH471-006
  • ACTRN12616001017415 (REGISTRY: ANZCTR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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