A Phase 1 Investigation of a Study Drug for Inflammatory Conditions in Healthy Adult Participants
Published: 09/30/2021
General Information:
This is a clinical trial with healthy participants to:
• measure how a single oral dose of the study drug affects the body and certain types of blood cells and enzymes
• measure the amount of study drug in your blood 48 hours after a single dose
• see how a new drug under study is tolerated, if there are any significant side effects and how people feel after taking it
Eligibility:
You may be eligible to participate if you are:
· An adult age 18-60
· 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.
Study Details:
Study Description
This is a study of an investigational drug for inflammatory conditions, such as ulcerative colitis and Crohn's disease. It consists of 1 oral dose of the study drug, 3 consecutive overnights (scheduled over the weekend), and 1 follow up phone call about 28-30 days after dosing. This is a Phase 1 study involving healthy volunteers to measure target occupancy of the enzymes affected by the study drug. 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 3 consecutive nights over one weekend. You will receive a single oral dose of the study drug the day after admission and will stay at the PCRU for about 48 hours after dosing. About 4 weeks after your dose, you will receive a phone call from study staff to ask questions and follow up on your participation.
All the study procedures will be clearly explained to you during screening. Throughout the study, staff will closely monitor your health status and collect data, such as the levels of the study drug in your blood.
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:
· Headache
· Infections of the upper respiratory tract
· Acne
· Diarrhea
· Nausea
· 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.