Investigation of safety, tolerability and pharmacokinetic properties of multiple doses of oral NNC0385-0434 in healthy, male Japanese participants

JRCT ID: jRCT2071210055

Registered date:27/08/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Familial hypercholesterolaemia, Hypercholesterolaemia
• Date of first enrollment: 19/08/2021
• Target sample size: 36
• Study type: Interventional

Intervention(s)

Multiple dose of NNC0385-0434 or placebo (10-day dosing)
Screening visit, in-house treatment (13 nights) and follow-up visit
Follow-up period afrer dosing is 55 days.
Trial duration is 62 - 98 days for each subject (depending on time of screening relative to dosing)

Outcome(s)

• Primary Outcome: Number of treatment emergent adverse events (TEAEs) [Time Frame: From pre-dose (day 1) until completion of the post-treatment period at follow-up (day 65)]

Secondary Outcome

1. AUC0-24h,0434,Day10,; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434
2. Cmax,0434,Day10,; the maximum plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
3. tmax,0434,Day10; the time to maximum observed plasma concentration of NNC0385-0434 after last dose of oral NNC0385-0434
4. t1/2,0434,Day10; the terminal half-life of NNC0385-0434 after last dose of oral NNC0385-0434
5. AUC0-24h,SNAC,Day10,; the area under the SNAC plasma concentration-time curve from time 0 to 24 h after last dose of oral NNC0385-0434
6. Cmax,SNAC,Day10; the maximum plasma concentration of SNAC after last dose of oral NNC0385-0434
7. tmax,SNAC,Day10; the time to maximum observed plasma concentration of SNAC after last dose of oral NNC0385-0434
8. t1/2,SNAC,Day10; the terminal half-life of SNAC after last dose of oral NNC0385-0434

Key inclusion & exclusion criteria

• Age minimum: >= 22age old
• Age maximum: <= 55age old
• Gender: Male

Include criteria

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male, aged 20-55 years (both inclusive) at the time of signing informed consent.
3. Both parents of Japanese descent.
4. Body weight >=54.0 kg
5. Body mass index (BMI) between 20.0 and 34.9 kg/m2 (both inclusive)
6. Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

• Exclude criteria: Any disorder, which in the investigators opinion might jeopardise participant safety or compliance with the protocol

Related Information

• Primary Sponsor: Sudoh Yuki
• Secondary ID(s): NCT05003440