A First Human Dose Study Investigating Safety and Concentration of Study Medicine in the Blood Following Once Daily Oral Dosing of NNC0560-0004 in Healthy Adults.
Phase 1
Completed
- Conditions
- Healthy Volunteers - Liver Diseases
- Interventions
- Drug: Placebo (NNC0560-0004)
- Registration Number
- NCT06133270
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers.
Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance.
This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans.
The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks.
Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (NNC0560-0004) Placebo (NNC0560-0004) Participant will be randomized to receive placebo in: Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) NNC0560-0004 NNC0560-0004 The study will be conducted in 3 parts. Participants will be randomized to receive NNC0560-0004 in Part A: Single ascending dose (SAD) Part B: Multiple ascending dose (MAD) No randomisation - only active treatment in Part C: Single dose
- Primary Outcome Measures
Name Time Method Part B: Number of treatment-emergent adverse events (TEAE) From pre-dose (day 1) to end of study, Part B (up to day 26) Number of events
Part C: Number of treatment-emergent adverse events (TEAE) From pre-dose (day 1) to end of study, Part C (up to day 84) Number of events
Part A: Number of treatment-emergent adverse events (TEAE) From pre-dose (day 1) to end of study, Part A (up to day 13) Number of events
- Secondary Outcome Measures
Name Time Method Part A: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose From pre-dose (day 1) to end of study, Part A (up to day 13) nmol/L
Part A: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose From pre-dose (day 1) to end of study, Part A (up to day 13) hour
Part A:t½, SD: the terminal half-life of NNC0560-0004 after a single dose From pre-dose (day 1) to end of study, Part A (up to day 13) hour
Part B: AUC0-24h, MD: the area under the NNC0560-0004 plasma concentration-time curve in the dosing interval after last dosing From pre-dose on day 14 until end of study, Part B (up to day 26) (24 hours post-dose) h\*nmol/L
Part B: Cmax, MD: the maximum plasma concentration of NNC0560-0004 after last dosing From pre-dose on day 14 to end of study, Part B (up to day 26) nmol/L
Part B:tmax, MD: the time to maximum concentration of NNC0560-0004 after last dosing From pre-dose on day 14 to end of study, Part B (up to day 26) hour
Part B:t½, MD: the terminal half-life of NNC0560-0004 after last dosing From pre-dose on day 14 to end of study, Part B (up to day 26) hour
Part A: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose From pre-dose (day 1) to end of study, Part A (up to day 13) h\*nmol/L
Part C: AUC0-∞, SD: the area under the NNC0560-0004 plasma concentration-time curve from time 0 to infinity after a single dose From pre-dose (day 1) to end of study, Part C (up to day 84) h\*nmol/L
Part C: Cmax, SD: the maximum plasma concentration of NNC0560-0004 after a single dose From pre-dose (day 1) to end of study, Part C (up to day 84) nmol/L
Part C: tmax, SD: the time to maximum concentration of NNC0560-0004 after a single dose From pre-dose (day 1) to end of study, Part C (up to day 84) hour
Part C: t½, SD: the terminal half-life of NNC0560-0004 after a single dose From pre-dose (day 1) to end of study, Part C (up to day 84) hour
Trial Locations
- Locations (1)
Northwick Park Hosptial
🇬🇧Watford, Middlesex, United Kingdom