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

Alexion Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Danicopan - LFC; Drug: Danicopan - Softgel; Drug: Danicopan - Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04940559

ACTRN12616001017415 (Registry Identifier)

ACH471-006

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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26 participants in 5 patient groups

Group 1: Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: Danicopan - Tablet

Drug: Danicopan - LFC

Group 1: Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: Danicopan - Tablet

Drug: Danicopan - LFC

Group 1: Sequence 3

Experimental group

Description:

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.

Treatment:

Drug: Danicopan - Tablet

Drug: Danicopan - LFC

Group 2: Sequence 1

Experimental group

Description:

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.

Treatment:

Drug: Danicopan - Softgel

Drug: Danicopan - LFC

Group 2: Sequence 2

Experimental group

Description:

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.

Treatment:

Drug: Danicopan - Softgel

Drug: Danicopan - LFC