Northwick Park Hosptial
Watford, Middlesex, HA1 3UJ, United Kingdom
NCT Number: NCT06133270
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.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Watford, Middlesex, HA1 3UJ, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Key inclusion criteria:
Key exclusion criteria:
a.eGFR below 90 ml/min/1.73m^2
NNC0560-0004, Oral administration (taken through the mouth)
Placebo matching NNC0560-0004, Oral administration (taken through the mouth)
Time frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
Number of events
Time frame: From pre-dose (day 1) to end of study, Part B (up to day 26)
Number of events
Time frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
Number of events
Time frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
h*nmol/L
Time frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
nmol/L
Time frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
hour
Time frame: From pre-dose (day 1) to end of study, Part A (up to day 13)
hour
Time frame: From pre-dose on day 14 until end of study, Part B (up to day 26) (24 hours post-dose)
h*nmol/L
Time frame: From pre-dose on day 14 to end of study, Part B (up to day 26)
nmol/L
Time frame: From pre-dose on day 14 to end of study, Part B (up to day 26)
hour
Time frame: From pre-dose on day 14 to end of study, Part B (up to day 26)
hour
Time frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
h*nmol/L
Time frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
nmol/L
Time frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
hour
Time frame: From pre-dose (day 1) to end of study, Part C (up to day 84)
hour
Novo Nordisk A/S
Industry
A Phase I, Randomised, Double Blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Once-daily Oral Doses of NNC0560-0004 in Healthy Humans, With an Additional Open Label Single Dose Cohort of CYP2D6 Poor Metabolizers.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.