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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04940559

Enrollment

Registered

2021-06-25

Start date

2016-08-02

Completion date

2016-10-05

Last updated

2021-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Danicopan, ALXN2040, ACH-0144471, Relative Bioavailability, LFC, Tablet, Softgel Capsule, Food Effect, Pharmacokinetics, Factor D Inhibitor, Safety

Brief 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.

Interventions

DRUGDanicopan - Tablet

Oral tablet.

DRUGDanicopan - Softgel

Oral softgel capsule.

DRUGDanicopan - LFC

Oral LFC.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Intervention model description

Group 1 followed a 3-treatment, 3-period crossover study design. Group 2 followed a 2-treatment, 2-period crossover study design.

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
PK: Maximum Plasma Concentration (Cmax) Of Danicopan After Treatment With Each Of The Three Formulations	Up to 96 hours postdose
PK: Time To Reach The Maximum Plasma Concentration (Tmax) Of Danicopan After Treatment With Each Of The Three Formulations	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	Up to 96 hours postdose

Secondary

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

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026