A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342713
• Other study ID #: BGB-45035-101
• Status: Recruiting
• Phase: Phase 1
• Start date: June 3, 2024
• Est. completion date: April 30, 2025

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: BeiGene
• Phone: 1-877-828-5568
• Email: ClinicalTrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is the first-in-human (FIH) study for BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants.

Study details include:

• The study duration will be up to 16 months.

• The treatment duration will be up to 14 days.

• Safety follow-up 30 days after last dose of study drug.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Healthy female participants of non-childbearing potential and/or male participants between the ages of 18 and 55 years inclusive (ages 18 and 45 years for Part C).

2. Female participants of non-childbearing potential must meet at least 1 of the following criteria:

1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum Follicle-Stimulating Hormone (FSH) level confirming the post-menopausal state.

2. Have undergone a documented hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy. All other female participants (including females with tubal ligations) are considered to be of childbearing potential.

3. BMI of 18 to 32 kg/m2; and a total body weight > 50 kg (110 lbs).

4. Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.

5. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

6. Nonsterile male participants must be willing to use a highly effective method of birth control and refrain from sperm donation for the duration of the study and for 90 days after the last dose of study drug.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

2. Any condition possibly affecting drug absorption (eg, gastrectomy or cholecystectomy).

3. A positive screen alcohol or drug screen.

4. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor) within 6 months of screening.

5. Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of investigational product, whichever is longer.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Autoimmune Diseases
• Healthy Adult Participants
• Healthy Participants
• Healthy Subjects
• Healthy Volunteers

Intervention

Drug:
• BGB-45035
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Australia	Cmax Clinical Research	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Adverse Events (AEs)		Up to approximately 1 year
Primary	Number of participants with clinically significant changes from baseline in clinical laboratory values	Laboratory values include hematology, clinical chemistry, coagulation, and urinalysis	Up to approximately 1 year
Primary	Number of participants with clinically significant changes from baseline in vital signs	Vital signs include blood pressure and pulse rate	Up to approximately 1 year
Primary	Number of participants with clinically significant changes from baseline in cardiac conduction intervals	as assessed via 12-lead electrocardiogram (ECG)	Up to approximately 1 year
Secondary	Area under the plasma concentration time curve from time zero to last quantifiable time(AUClast)		Up to approximately 1 year
Secondary	Area under the plasma concentration time curve from time zero to infinite time (AUCinf)		Up to approximately 1 year
Secondary	Area under the plasma concentration time curve from time zero to end of dosing interval (AUCtau)		Up to approximately 1 year
Secondary	Maximum observed plasma concentration (Cmax)		Up to approximately 1 year
Secondary	Time to maximum plasma concentration (Tmax)		Up to approximately 1 year
Secondary	Trough plasma concentration (Ctrough)		Up to approximately 1 year
Secondary	Half life (t½)		Up to approximately 1 year
Secondary	Apparent systemic clearance (CL/F)		Up to approximately 1 year
Secondary	Apparent volume of distribution (Vz/F)		Up to approximately 1 year
Secondary	Accumulation Ratios		Up to approximately 1 year