A study in HV of the PK of CC-99677 and its effects on other drugs
Research type
Research Study
Full title
A Phase 1, Open-Label Study in Healthy Adult Subjects to Evaluate Effects of Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-99677, and the Effects of CC-99677 on the Pharmacokinetics of Digoxin, Metformin, Methotrexate, Midazolam, Rosuvastatin, and Sulfasalazine
IRAS ID
275597
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Celgene Corporation
Eudract number
2019-003523-38
Duration of Study in the UK
0 years, 5 months, 0 days
Research summary
Richmond Pharmacology are conducting a clinical study with an experimental drug known as CC-99677. This study has three parts and involves healthy volunteers. CC-99677 is being developed by Celgene as a treatment for rheumatological disorders, in particular ankylosing spondylitis (AS).
AS is an inflammatory condition affecting the joints of the spine. There is currently no cure for the condition and management is based on improving symptoms. It occurs in 0.5-1.5% of the general population and typically affects young adults[1]. AS typically causes chronic inflammatory back pain and in addition can affect other areas of the body including the eye, heart and bowel. It can be very debilitating and greatly affects quality of life. There is urgent need to develop better treatment options.
CC-99677 has been studied in the laboratory, in animal studies and in a first-in-human study. It was investigated on 97 healthy volunteers and found to be well-tolerated in single and multiple doses. The adverse events were all mild in nature with exception of one which was moderate but not deemed by the investigator to be related to CC-99677. There were no serious adverse events and no stopping criteria were met in any part.
The main aim of this study is to determine whether CC-99677 interacts with any other medications. We will investigate this using six licensed medications that are known to have specific effects on enzymes and transporter proteins that can influence how drugs behave in the body. The medications we will use are called digoxin, metformin, methotrexate, midazolam, rosuvastatin and sulfasalazine.
We intend to recruit approximately 48 healthy participants to complete the trial.References:
[1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5811203/REC name
London - London Bridge Research Ethics Committee
REC reference
20/LO/0001
Date of REC Opinion
6 Feb 2020
REC opinion
Favourable Opinion