Phase
Condition
Healthy Volunteers
Treatment
Rifampin
Golcadomide
Itraconazole
Clinical Study ID
Ages 18-55 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy male and female non smoking participants, of any race, as determined by theinvestigator to have no clinically significant deviation from normal, in medicalhistory and physical examination which correspond to a condition that couldpotentially increase the risk for the participants, or jeopardize the integrity ofthe study data, in 12-lead ECG measurements, vital signs, and clinical laboratorydeterminations, at screening and at check-in.
Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2for participants.
Participant is afebrile (febrile is defined as ≥ 38°C or ≥ 100.4°F), with systolicblood pressure ≥ 90 and ≤ 140 mmHg, diastolic blood pressure ≥ 50 and ≤ 90 mmHg, andpulse rate ≥ 40 and ≤ 90 beats per minute at screening, confirmed by repeat, as perclinical site's standard.
Must have a normal or clinically acceptable 12-lead ECG at screening: Participantsmust have a corrected QT interval using QTcF value ≤ 450 msec.
Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1.
Must have adequate laboratory test results for renal and hepatic function asassessed by the PI (Principal Investigator). Laboratory testing may be repeated tofind all possible well-qualified participants.
Exclusion
Exclusion Criteria:
Any significant acute or chronic medical illness that presents a potential risk tothe participant in the opinion of the investigator and/or may compromise theobjectives of the study.
History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal,respiratory, or genitourinary (GU) abnormalities/diseases.
Has any surgical or medical conditions possibly affecting drug absorption,distribution, metabolism and excretion (ADME). Appendectomy and cholecystectomy areacceptable. Prior procedures of unclear ADME significance should be reviewed withthe Sponsor's Medical Monitor.
Other protocol-defined Inclusion/Exclusion criteria apply.
Study Design
Connect with a study center
CenExel CNS
Atlanta, Georgia 30331
United StatesActive - Recruiting
Local Institution - 0002
Atlanta, Georgia 30331
United StatesSite Not Available
ICON Lenexa
Lenexa, Kansas 66219
United StatesActive - Recruiting
Local Institution - 0001
Lenexa, Kansas 66219
United StatesSite Not Available
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