Study of a Single Dose of Danicopan in Healthy Participants
Status and phase
Completed
Phase 1
Conditions
Healthy
Treatments
Drug: Danicopan
Drug: Placebo
Details and patient eligibility
About
This was a single ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (200 milligrams [mg], 600 mg, 1200 mg, 2400 mg) and dose-matched placebo were administered under fasted and fed conditions.
Enrollment
44 patients
Sex
All
Ages
21 to 55 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Healthy defined as having no clinically relevant abnormalities identified by a detailed medical history, physical examination, blood pressure and pulse rate measurements, 12-lead electrocardiogram, and clinical laboratory tests.
- Body mass index of 18 to 30 kilograms (kg)/meter squared with a minimum body weight of 50 kg.
Exclusion criteria
- History or clinically relevant evidence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
- Any condition possibly affecting drug absorption (for example, gastrectomy), cholecystectomy to be considered acceptable.
- Body temperature ≥ 38°Celcius on Day -1 or Day 1 Hour 0; history of febrile illness or other evidence of infection within 14 days prior to study drug administration.
- Current tobacco/nicotine users; consumption of any alcohol within 72 hours before study drug administration or a history of regular alcohol consumption exceeding 21 drinks/week within 6 months of Screening; positive urine drug screen at Screening or Day -1.
- Clinically significant laboratory abnormalities at either Screening or Day -1.
Trial design
Primary purpose
Basic Science
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
44 participants in 5 patient groups
Group 1: 200 mg
Experimental group
Description:
All participants (fasted) received either 200 mg of danicopan as a single oral dose or dose-matched placebo.
Treatment:
Drug: Danicopan
Drug: Placebo
Group 2: 600 mg
Experimental group
Description:
All participants (fasted) received either 600 mg of danicopan as a single oral dose or dose-matched placebo.
Treatment:
Drug: Danicopan
Drug: Placebo
Group 3: 1200 mg
Experimental group
Description:
All participants (fasted) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.
Treatment:
Drug: Danicopan
Drug: Placebo
Group 4: 2400 mg
Experimental group
Description:
All participants (fasted) received either 2400 mg of danicopan administered as 2 single doses of 1200 mg each, 12 hours apart, or dose-matched placebo.
Treatment:
Drug: Danicopan
Drug: Placebo
Group 5: 1200 mg
Experimental group
Description:
All participants (fed) received either 1200 mg of danicopan as a single oral dose or dose-matched placebo.
Treatment:
Drug: Danicopan
Drug: Placebo
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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