Phase 1 PK study of ACH-0144471 in healthy subjects (QCL118122)
Research type
Research Study
Full title
A Phase 1 Study to Evaluate the Pharmacokinetic Profile of ACH-0144471 Following Administration of Modified Release Prototype Formulations in Healthy Subjects
IRAS ID
235120
Contact name
Margaret Foley
Contact email
Sponsor organisation
Achillion Pharmaceuticals, Inc.
Eudract number
2017-003525-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 4 months, 20 days
Research summary
The Sponsor is developing the study drug, ACH-0144471, for the potential treatment of paroxysmal nocturnal haemoglobinuria (PNH), C3 glomerulopathy (C3G), and other complement mediated diseases (diseases that affect part of the immune system which is the body’s natural defence against disease). These diseases are associated with excessive activity of a part of the immune system response, called the complement system. ACH-0144471 works by blocking the action of an enzyme which stops the complement system from amplifying.
This study will look at how different formulations (recipes) of the study drug are taken up by the body. The safety and tolerability of ACH-0144471 will also be investigated.
The study will consist of 1 part involving up to 5 periods, 14 healthy subjects will be enrolled. Subjects will attend the clinical unit on up to 5 occasions to receive one dose of ACH-047771; a total of 5 doses. Treatment regimens A-E will be dosed at each period, with Periods 4 and 5 being optional. In Regimen A, subjects will receive a dose of 400 mg of ACH-0144471 prototype tablet. After Periods 1, 2, 3 and 4; an interim review meeting will be held to decide the dose to be given in the subsequent regimen, and whether Periods 4 and 5 are required. The maximum dose that may be given will be equivalent to dosing a 500 mg immediate release formulation twice daily. For each period, subjects will be dosed on Day 1 and remain in clinic until Day 3. Subjects will return for a blood sample on Day 4. There will be a break of at least 14 days between each product administration. A follow-up visit will take place 8 to 12 days after the subject’s final dose to ensure the ongoing wellbeing of the subjects.
REC name
HSC REC B
REC reference
17/NI/0214
Date of REC Opinion
20 Nov 2017
REC opinion
Further Information Favourable Opinion