A Study Investigating Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of NNC0363-1063 in Healthy Participants and Participants With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Part 1 SAD: Number of adverse events
研究概览
简要总结
This study will look into testing a new medicine called NNC0363-1063 which may be used to treat people with diabetes. The study consists of three parts: Part 1 is a single ascending dose (SAD) study that comprises two subtypes: Part 1A conducted in healthy participants and Part 1B conducted in participants with type 1 diabetes (T1D). This study part will last for about 1½ to 5½ weeks. Part 2 is a proof-of-principle (PoP) study part conducted in participants with T1D and will last for about 3½ to 8½ weeks. Part 3 is a meal test multiple dose study part conducted in participants with T1D and will last for 7 to 11 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)
盲法说明
Part 1 SAD and Part 3 Meal test are double-blind study parts. Sponsor staff involved in the clinical trial is masked according to company standard procedures. Part 2 is open-label study part.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Part 1A SAD (healthy participants)
- •Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body mass index between 18.5-29.9 kilogram per square metre( kg/m^2) (both inclusive) at the day of screening.
- •Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
- •Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
- •Male or female of non-child bearing potential. Non-child bearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
- •Age 18-64 years (both inclusive) at the time of signing the informed consent.
- •Body mass index between 18.5-29.9 kg/m^2 (both inclusive) at the day of screening.
- •Diagnosed with type 1 diabetes mellitus greater than or equal to( ≥)1 year prior to the day of screening.
- •Considered to be generally healthy (except for mild conditions under stable treatment associated with type 1 diabetes mellitus) based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Part 1A SAD (healthy participants)
- •Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- •Any condition, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
- •Part 1B SAD, Part 2 PoP and Part 3 Meal test (participants with T1D)
- •Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
- •Any condition, except for mild conditions under stable treatment associated with type 1 diabetes mellitus, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
研究组 & 干预措施
Part 1A: SAD: Placebo
Participants will receive NNC0363-1063 matching placebo subcutaneously.
干预措施: Placebo (Drug)
Part 1B: SAD: NNC0363-1063
Participants will receive NNC0363-1063 subcutaneously.
干预措施: NNC0363-1063 (Drug)
Part 1B: SAD: Insulin degludec
Participants will receive insulin degludec subcutaneously.
干预措施: Insulin degludec (Drug)
Part 2: PoP: NNC0363-1063
Participants will receive NNC0363-1063 subcutaneously.
干预措施: NNC0363-1063 (Drug)
Part 3 Meal test: NNC0363-1063
Participants will receive NNC0363-1063 subcutaneously.
干预措施: NNC0363-1063 (Drug)
Part 3 Meal test: Insulin detemir
Participants will receive insulin detemir subcutaneously.
干预措施: Insulin detemir (Drug)
Part 1A: SAD: NNC0363-1063
Participants will receive single dose of NNC0363-1063 subcutaneously.
干预措施: NNC0363-1063 (Drug)
结局指标
主要结局
Part 1 SAD: Number of adverse events
时间窗: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Measured in number of events.
Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose
时间窗: From IMP administration at day 1 up to 7 days
Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]).
Part 1 SAD: Number of adverse events
时间窗: From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8)
Measured in number of events.
Part 2 PoP: CL/F,I1063,SD- Apparent serum clearance of NNC0363-1063 after a single dose
时间窗: From IMP administration at day 1 up to 7 days
Measured in millilitre per hour\*kilogram (mL/\[h\*kg\]).
Part 3 Meal test: AUC,PG,meal: Area under the plasma glucose concentration-time curve at steady state
时间窗: At day 2 of visit 2 and visit 3 after initiation of meal test
Measured in hours\*millimoles per litre (h\*mmol/L).
次要结局
- Part 1 SAD: Number of hypoglycaemic episodes(From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8))
- Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose(Up to 7 days)
- Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose(Up to 2 days)
- Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose(Up to 7 days)
- Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose(Up to 7 days)
- Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose(Up to 2 days)
- Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose(Up to 7 days)
- Part 1 SAD: Number of hypoglycaemic episodes(From investigational medicinal product (IMP) administration (day 1) until end of study visit (day 8))
- Part 1 SAD: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose(Up to 7 days)
- Part 1 SAD: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose(Up to 2 days)
- Part 1 SAD: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose(Up to 7 days)
- Part 2 PoP: AUC0-inf,I1063,SD: Area under the serum NNC0363-1063 concentration-time curve from 0 to infinity after a single dose(Up to 7 days)
- Part 2 PoP: AUC,I1063,SD- Area under the serum NNC0363-1063 concentration time curve after a single dose(Up to 2 days)
- Part 2 PoP: Cmax,I1063,SD- Maximum observed serum NNC0363-1063 concentration after a single dose(Up to 7 days)
- Part 3 Meal test: AUC0-1h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 1 hour after initiation of the meal test at steady state(From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3))
- Part 3 Meal test: AUC0-2h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 2 hours after initiation of the meal test at steady state(From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3))
- Part 3 Meal test: AUC0-4h,PG,mean: Area under the plasma glucose concentration-time curve from 0 to 4 hours after initiation of the meal test at steady state(From 0 hours to 4 hours after initiation of the meal test (day 2 of visit 2 and visit 3))
- Part 3 Meal test: AUC0-6h,PG,meal: Area under the plasma glucose concentration-time curve from 0 to 6 hours after initiation of the meal test at steady state(From 0 hours to 6 hours after initiation of the meal test (day 2 of visit 2 and visit 3))
- Part 3 Meal test: PGmax,meal: Maximum observed plasma glucose concentration at steady state(At day 2 of visit 2 and visit 3 after initiation of meal test)
- Part 3 Meal test: tPGmax,meal: Time to maximum observed plasma glucose concentration from at steady state(At day 2 of visit 2 and visit 3 after initiation of meal test)
- Part 3 Meal test: ΔPGav,0-1h,meal: Mean change in plasma glucose from 0 to 1 hour after initiation of the meal test at steady state(From 0 hours to 1 hour after initiation of the meal test (day 2 of visit 2 and visit 3))
- Part 3 Meal test: ΔPGav,0-2h,meal: Mean change in plasma glucose from 0 to 2 hours after initiation of the meal test at steady state(From 0 hours to 2 hours after initiation of the meal test (day 2 of visit 2 and visit 3))
- Part 3 Meal test: AUCτ,I1063,SS: Area under the serum NNC0363-1063 concentration-time curve during one dosing interval at steady state(At day 2 of visit 2 and visit 3 after last IMP administration)
- Part 3 Meal test: Cmax,I1063,SS: Maximum observed serum NNC0363-1063 concentration during one dosing interval at steady state(At day 2 of visit 2 and visit 3 after last IMP administration)
- Part 3 Meal test: Number of adverse events(From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3))
- Part 3 Meal test: Number of hypoglycaemic episodes(From first IMP administration (day 1 of visit 2 and visit 3) until 24 hours after last IMP administration (day 2 of visit 2 and visit 3))