A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Open-label, 2-part, 2-period, Fixed-sequence, Crossover Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Pharmacokinetics of Golcadomide (BMS-986369) in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363630
• Other study ID #: CA073-1000
• Status: Recruiting
• Phase: Phase 1
• Start date: April 23, 2024
• Est. completion date: August 19, 2024

Study information

• Verified date: May 2024
• Source: Celgene
• Contact: BMS Study Connect Contact http://www.bmsstudyconnect.com/
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the drug-drug interaction (DDI) potential of coadministration of itraconazole or rifampin on the single dose drug levels of golcadomide.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 19, 2024
• Est. primary completion date: August 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male and female non smoking participants, of any race, as determined by the investigator to have no clinically significant deviation from normal, in medical history and physical examination which correspond to a condition that could potentially increase the risk for the participants, or jeopardize the integrity of the study data, in 12-lead ECG measurements, vital signs, and clinical laboratory determinations, at screening and at check-in.
• Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants.
• Participant is afebrile (febrile is defined as = 38°C or = 100.4°F), with systolic blood pressure = 90 and = 140 mmHg, diastolic blood pressure = 50 and = 90 mmHg, and pulse rate = 40 and = 90 beats per minute at screening, confirmed by repeat, as per clinical site's standard.
• Must have a normal or clinically acceptable 12-lead ECG at screening: Participants must 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 as assessed by the PI (Principal Investigator). Laboratory testing may be repeated to find all possible well-qualified participants.

Exclusion Criteria:

• Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives 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 are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Itraconazole
Specified dose on specified days.
• Rifampin
Specified dose on specified days
• Golcadomide
Specified dose on specified days

Locations

Country	Name	City	State
United States	CenExel CNS	Atlanta	Georgia
United States	ICON Lenexa	Lenexa	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum observed plasma concentration (Cmax)		Up to Day 67
Primary	Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))		Up to Day 67
Primary	Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))		Up to Day 67
Secondary	Number of participants with adverse events (AEs)		Up to Day 69
Secondary	Number of participants with physical exam abnormalities		Up to Day 69
Secondary	Number of participants with vital sign abnormalities		Up to Day 69
Secondary	Number of participants with clinical laboratory safety test abnormalities		Up to Day 69
Secondary	Number of participants with electrocardiogram abnormalities		Up to Day 69
Secondary	Number of participants with concomitant medications		Up to Day 69
Secondary	Number of participants with concomitant procedures		Up to Day 69
Secondary	Time of maximum observed plasma concentration (Tmax)		Up to Day 67
Secondary	Apparent terminal phase half-life (T-HALF)		Up to Day 67
Secondary	Apparent total body clearance (CLT/F)		Up to Day 67
Secondary	Apparent volume of distribution (Vz/F)		Up to Day 67

External Links

•   BMS Clinical Trial Information