NCT06069895已完成1 期
Investigation of Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-6856 in Healthy Participants, Including a Subset of Healthy Japanese Participants
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Number of adverse events (AEs)
研究概览
简要总结
NNC0113-6856 is a new medicine which may help participants with type 2 diabetes to improve blood sugar control. NNC0113-6856 is slowly converted in the body to semaglutide, a substance similar to a hormone (signaling substance) in the body. The main purpose of this study will be to evaluate the safety of different strengths of NNC0113-6856 when given as multiple administrations, and the amount of NNC0113-6856 in the blood will be measured as well as the amount of specific parts (including semaglutide). Participants will either get multiple doses of the new medicine NNC0113-6856 or multiple doses of placebo (a "dummy" medicine that looks like the new medicine but is without any active ingredient). Whether participants get the new medicine or placebo is decided by chance. The duration of the study could last up to 25 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female.
- •Age 18-55 years (both inclusive) at the time of signing the informed consent.
- •Body mass index (BMI) between 21.0 and 29.9 kilograms per meter square (kg/m^2) (both inclusive) at screening.
- •Additional for healthy Japanese participants:
- •First generation Japanese (Japanese born participants).
排除标准
- •HbA1c greater than or equal to (≥) 6.5 percent (%) (48 millimoles per mole [mmol/mol]) at screening.
- •Any of the below laboratory safety parameters at screening outside the below laboratory range, see "Log of laboratory ranges used for laboratory parameter exclusion criterion" for specific values:
- •Alanine Aminotransferase (ALT) greater than (>) upper normal limit (UNL) +10%
- •Aspartate aminotransferase (AST) > UNL+20%
- •Total bilirubin > UNL+20%
- •Creatinine > UNL+10%
- •International normalised ratio (INR) > UNL
研究组 & 干预措施
NNC0113-6856
Experimental
Participants will receive NNC0113-6856 oral tablets.
干预措施: NNC0113-6856 (Drug)
Placebo
Experimental
Participants will receive NNC0113-6856 matching placebo oral tablets.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of adverse events (AEs)
时间窗: From time of first dosing (day 1) until completion of the follow-up visit (day 148)
Measured as number of events.
次要结局
- Part 2 (DC): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106)
- Part 2 (DC): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106)
- Part 3 (JP): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 3 (JP): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 1 (MAD): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 2 (DC): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106)
- Part 1 Multiple ascending dose (MAD): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 1 (MAD): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 1 (MAD): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 2 Dosing condition (DC): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106)
- Part 3 Japanese (JP): AUCτ,sema,SS: area under the semaglutide plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 3 (JP): Cmax,sema,SS: maximum observed plasma concentration of semaglutide at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 3 (JP): Cmax,6856,SS: maximum observed plasma concentration of NNC0113-6856 at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 1 (MAD): AUCτ,4768,SS: area under the NNC0113-4768 plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 2 (DC): Cmax,4768,SS: maximum observed plasma concentration of NNC0113-4768 at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106)
- Part 1 (MAD): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
- Part 2 (DC): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 50, 78 and 106)
- Part 3 (JP): AUCτ,6856,SS: area under the NNC0113-6856 plasma concentration-time curve during a dosing interval τ at steady state(From 0 to 168 hours after fourth dosing with the same dose at days 22, 50, 78 and 106)
研究者
研究点 (1)
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