A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Day Dose Study to Assess the Safety and Tolerability of JNJ-67670187 in Healthy Participants
- Conditions
- IBDUlcerative colitis10017969
- Registration Number
- NL-OMON47984
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 98
1. Be a male or female.
2. Be 18 (or the legal age of consent in the jurisdiction in which the study is
taking place) to 60 years of age, inclusive.
3. Have a body mass index (BMI) between 18 and 30 kilogram per square metre
(kg/m^2) inclusive, and a body weight of at least 50 kilogram (kg).
4. Be otherwise healthy on the basis of physical examination, medical history,
and vital signs, and 12-lead electrocardiogram (ECG) performed at screening and
at admission.
5. Be otherwise healthy on the basis of clinical laboratory tests performed at
screening and at admission. If the results of the serum chemistry panel,
hematology, or urinalysis are outside the normal reference ranges, the
participant may be included only if the investigator judges the abnormalities
or deviations from normal to be not clinically significant. This determination
must be recorded in the participant's source documents and initialed by the
investigator.
Coexisting Medical Conditions or Past Medical History
1. History of any clinically significant medical illness or medical disorders
the investigator considers should exclude the participant, including (but not
limited to), neuromuscular, hematological disease, immune deficiency state,
respiratory disease, hepatic or gastrointestinal (GI) disease, neurological or
psychiatric disease, ophthalmological disorders, neoplastic disease, renal or
urinary tract diseases, or dermatological disease.
2. Has any condition for which, in the opinion of the investigator,
participation would not be in the best interest of the participant (eg,
compromise the well being) or that could prevent, limit, or confound the
protocol-specified assessments.
3. Inability to swallow capsules (dysphagia).
4. Has a known intolerance or allergy to vancomycin, polyethylene glycol (PEG)
laxatives, or any of the excipients in the study interventions.
5. Has a known intolerance or allergy to 2 or more classes of the antibiotics
that may be used to treat infection with the study intervention (tigecycline,
metronidazole, ampicillin/sulbactam, amoxicillin/clavulanate, meropenem,
imipenem/cilastatin, and/or vancomycin).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the safety and tolerability of JNJ-67670187 (11-strain Clostridia<br /><br>mix) compared with placebo after administration of:<br /><br><br /><br>Single Dose administered orally once in healthy participants (Part 1).<br /><br><br /><br>Multiple Dose administered orally once daily over 14 consecutive days with and<br /><br>without bowel preparation pretreatments in healthy participants (Parts 2 and<br /><br>3).</p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the colonization dynamics of JNJ-67670187 in the stool following<br /><br>single and multiple oral study intervention administrations (Parts 1 and 2).<br /><br>To assess the colonization dynamics of JNJ-67670187 following multiple oral<br /><br>study intervention administrations with specific pretreatments (Parts 2 and 3).</p><br>