Study of a Single Dose of Danicopan in Healthy Participants

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04889677
• Other study ID #: ACH471-001
• Status: Completed
• Phase: Phase 1
• Start date: February 4, 2016
• Est. completion date: June 21, 2016

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 21, 2016
• Est. primary completion date: June 21, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

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, 

References & Publications (1)

Wiles JA, Galvan MD, Podos SD, Geffner M, Huang M. Discovery and Development of the Oral Complement Factor D Inhibitor Danicopan (ACH-4471). Curr Med Chem. 2020;27(25):4165-4180. doi: 10.2174/0929867326666191001130342. Review. — View Citation

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 28
Secondary	Area Under The Plasma Concentration-time Curve Extrapolated To Infinity (AUC0-inf) Of Danicopan Under Both Fed And Fasted Conditions		Up to 144 hours postdose
Secondary	Maximal Plasma Concentration (Cmax) Of Danicopan Under Both Fed And Fasted Conditions		Up to 144 hours postdose
Secondary	Time To Reach The Maximal Plasma Concentration (Tmax) Of Danicopan Under Both Fed And Fasted Conditions		Up to 144 hours postdose
Secondary	Relationship Between Alternative Pathway Inhibition And Danicopan Plasma Concentrations		Up to 144 hours postdose