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A phase I, open-label, single-dose, randomized, cross-over study to evaluate BLZ945 granule for suspension in healthy participants: relative bioavailability in comparison to BLZ945 capsule and food effect (CBLZ945C12102)

A study to evaluate the relative bioavailability of drug substance and formulation variants of BLZ945 and food effect in healthy participants (CBLZ945C12102)

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

rinshoshiken.toroku@novartis.com

Maruyama Hideki

Novartis Pharma. K.K.

Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan

+81-120-003-293

rinshoshiken.toroku@novartis.com

Not Recruiting

Aug. 14, 2023

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

other

Japanese healthy male and female 18 to 55 years of age, inclusive, and in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and initial baseline.
- Participants must weigh at least 40.0 kg to participate in the study and must have a Body Mass Index (BMI) within the range of 18-30 kg/m2 at screening.
- At screening and initial baseline, vital signs (body temperature, systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the participant has rested at least 3 minutes. Sitting vital signs should be within the following ranges:
- Axillary body temperature, 35.0-37.5 degree
- Systolic blood pressure, 90-139 mm Hg
- Diastolic blood pressure, 50-89 mm Hg
- Pulse rate, 40-90 bpm

- Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or over-the-counter (OTC) medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing.
- Significant illness, including infectious diseases that has not resolved within 30 days prior to baseline, or positive Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) test results at screening or baseline, or contact with a known case of Coronavirus Disease 2019 (COVID-19) infection in the 2 weeks prior to baseline.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during the study and for 14 days after stopping study treatment.
- Sexually active males unwilling to use a condom during intercourse during the study and for 14 days after stopping study treatment. A condom is required for all sexually active male participants to prevent them from fathering a child AND to prevent delivery of study treatment via seminal fluid to their partner. In addition, male participants must not donate sperm for the time period specified above.
- Participants unwilling to comply with lifestyle restrictions during the study period.

Both

Healthy participants

- Regimen 1 for Arm 1: BLZ945 will be randomized in a 1:1:1 ratio to one of 3 sequences.
- Regimen 2 for Arm 2: BLZ945 will be randomized in a 1:1 ratio to one of 2 sequences.
- Arm 3: BLZ945 granule will be administered under fasted condition

Primary PK parameters in plasma: AUClast, AUCinf, Cmax

+81-3-6665-0572

July. 28, 2023

No

none