Study of Multiple Doses of Danicopan in Healthy Participants

Healthy Clinical Trial

Official title:

A Multiple Ascending Dose Study To Assess Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of ACH-0144471 In Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889690
• Other study ID #: ACH471-002
• Status: Completed
• Phase: Phase 1
• Start date: May 21, 2016
• Est. completion date: January 11, 2017

Study information

• Verified date: May 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a multiple ascending dose, randomized, double-blind study assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of danicopan in healthy participants. Four different doses (75 milligrams [mg], 200 mg, 500 mg, 800 mg) and dose-matched placebo were administered under fasted conditions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: January 11, 2017
• Est. primary completion date: January 11, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy was defined as having no clinically relevant abnormalities identified by a detailed medical history, physical exam, blood pressure and heart 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 (including gastrectomy and cholecystectomy).

• Body temperature greater than or equal to 38°Celcius on Day -1 or Day 1, Hour 0; history of febrile illness or other evidence of infection within 14 days prior to first study drug administration.

• Current tobacco/nicotine user; consumption of any alcohol within 72 hours before first study drug administration or have 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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Danicopan

• Placebo

Locations

Country	Name	City	State
New Zealand	Clinical Trial Site	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Of Serious Adverse Events, Grade 3 Or 4 Adverse Events (AEs), AEs Leading To Discontinuation, And Clinically Significant Laboratory Abnormalities And Electrocardiogram Abnormalities		Day 1 through Day 42
Secondary	Maximum Observed Plasma Concentration (Cmax) Of Danicopan		Up to 16 hours postdose
Secondary	Time To Maximum Observed Plasma Concentration (Tmax) Of Danicopan		Up to 16 hours postdose
Secondary	Area Under The Plasma Concentration Versus Time Curve Over The Dosing Interval (AUCtau) Of Danicopan		Up to 16 hours postdose
Secondary	Activity Of Danicopan As Measured By Alternative Pathway (AP) Wieslab Assay		Up to 16 hours postdose
Secondary	Relationship Between AP Inhibition And Danicopan Plasma Concentrations		Up to 16 hours postdose