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

NCT04940559 | Completed Phase 1

• 2 other identifiers: ACH471-006ACTRN12616001017415
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• PK: Cmax Of Danicopan After Treatment With The Tablet Under Fed And Fasted Conditions

  Up to 96 hours postdose

• 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

• Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), And AEs Leading To Discontinuation

  Day 1 through Day 39

Study Arms (5)

Group 1: Sequence 1

EXPERIMENTAL

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; Drug: Danicopan - LFC

Group 1: Sequence 2

EXPERIMENTAL

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; Drug: Danicopan - LFC

Group 1: Sequence 3

EXPERIMENTAL

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; Drug: Danicopan - LFC

Group 2: Sequence 1

EXPERIMENTAL

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 - Softgel; Drug: Danicopan - LFC

Group 2: Sequence 2

EXPERIMENTAL

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 - Softgel; Drug: Danicopan - LFC

Interventions

Danicopan - Tablet DRUG

Oral tablet.

Also known as: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Group 1: Sequence 1; Group 1: Sequence 2; Group 1: Sequence 3

Danicopan - Softgel DRUG

Oral softgel capsule.

Also known as: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Group 2: Sequence 1; Group 2: Sequence 2

Danicopan - LFC DRUG

Oral LFC.

Also known as: ALXN2040, ACH-0144471 (formerly), ACH-4471, ACH4471, 4471

Group 1: Sequence 1; Group 1: Sequence 2; Group 1: Sequence 3; Group 2: Sequence 1; Group 2: Sequence 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Achillion, a wholly owned subsidiary of Alexion: collaborator

Study Sites (1)

Clinical Trial Site

Auckland, New Zealand

Location

MeSH Terms

Interventions

danicopan; rhoA GTP-Binding Protein

Intervention Hierarchy (Ancestors)

rho GTP-Binding Proteins; Monomeric GTP-Binding Proteins; GTP-Binding Proteins; GTP Phosphohydrolases; Acid Anhydride Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Intracellular Signaling Peptides and Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 25, 2021
• Study Start: August 2, 2016
• Primary Completion: October 5, 2016
• Study Completion: October 5, 2016
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

NZ (1)