A Phase 1 Study of Drug Interactions with a Study Drug for Inflammatory Conditions
This is a clinical trial with healthy participants to:
• see how the study drug is tolerated, if there are significant side effects, and how people feel after taking it when given with a single dose of another medication (drug B)
• see if multiple doses of the study drug have an effect on the amount of drug B in your blood after a single dose
• measure how much of drug B is in your blood after you take a single dose
You may be eligible to participate if you are:
· An adult age 18-65
· In overall good health (do not have a current medical condition)
· Willing to travel to our research facility in New Haven, CT
There are other eligibility criteria for this study that will be discussed prior to your participation. These are assessed through a phone pre-screening and an in-person screening appointment, which is similar to a regular physical exam.
This is a Phase 1 study involving healthy volunteers to assess the effects of an investigational drug for inflammatory conditions, such as ulcerative colitis and Crohn's disease, when taken with an additional medication (drug B). It consists of up to 10 once-daily doses of the study drug and 2 doses of drug B, 15 consecutive overnight stays at our research facility, and 1 follow up phone call about 28-35 days after dosing. All of the doses are given by mouth.
Healthy volunteers are a vital part of clinical trials and help us to understand more about an investigational medicine before moving forward into later phases of drug development. Most treatments cannot be made available to patients without first being tested in healthy volunteers.
Description of Treatment or Intervention (Mechanism of Action)
The study drug works by inhibiting a type of enzyme in the body called a kinase. The inhibition of specific kinases can result in modulation of common cytokine pathways, which are normally associated with inflammation throughout the body. Therefore, by affecting these pathways, the study drug is being investigated as a potential treatment for inflammatory conditions such as ulcerative colitis (UC), Crohn's disease (CD), alopecia areata (AA), vitiligo, and rheumatoid arthritis (RA).
Patient Participation Requirements
If this study may be a fit for you, you will be invited to a screening visit at our facility in New Haven, CT. If you qualify for the study, there may be a period of up to 28 days before dosing begins.
If you choose to participate, you will be asked to stay at our facility for 15 consecutive nights. During your stay, you will receive up to 10 once-daily doses of the study drug and 2 doses of an additional medication to see if there is any effect when taken together. All doses are given orally (by mouth).
Throughout the study, staff will closely monitor your health status and collect data, such as the levels of the study drug in your blood. All study procedures will be clearly explained to you during screening.
Possible Risks & Side Effects
Taking part in this study has some risks. The study drug or procedure(s) may make you feel unwell or uncomfortable or could harm you.
In previous studies (156 people total), the study drug was generally well tolerated. However, the most commonly reported side effects in a study of patients with AA were:
· Infections of the upper respiratory tract
· Skin infections
These are not the only risks of participating in this study. All risks and side effects will be thoroughly covered during the informed consent process prior to any study participation. The informed consent document can also be downloaded online on our website.
Progress to Date
The study drug has been studied in the following:
· Healthy participants (in single doses up to 800 mg and multiple doses up to 400 mg daily for 14 days)
· Patients with RA (at the dose of 200 mg daily for 8 weeks)
· Patients with AA (at a starting dose of 200 mg daily for 4 weeks, followed by a maintenance dosing of 50 mg daily for 20 weeks)
There are also ongoing studies of the study drug in patients with RA, UC, CD, AA, and vitiligo.