Phase 1 study to assess safety and PK of SAD and MAD dosing of NNC0560-0004 in healthy participants
Research type
Research Study
Full title
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
IRAS ID
1008024
Contact name
Jesper Clausen
Contact email
Sponsor organisation
Novo Nordisk A/S
Research summary
This is a phase I, randomised, double blind, placebo-controlled trial, with an additional open label single dose group, with at least 80 healthy female (of non-childbearing potential) and male subjects (both aged 18-55 years) at a single centre.
The main purpose is to assess the safety and tolerability following ascending single (Part A) and multiple oral doses (one dose per day over 14 days, Part B) as well as a single dose (Part C) of NNC0560-0004 under consideration of participants’ metaboliser-types (defines how quickly NNC0560-0004 is eliminated from the body), with slow metabolisers being (only) included in Part C.
Furthermore, the pharmacokinetics of single and oral doses of NNC0560-0004 will be assessed. Pharmacokinetics refers to how the trial medicine is taken up, broken down and finally removed from the body. Additionally, markers that reflect the effect of NNC0560-0004 will be measured. The influence of fasted and fed conditions (Part B) will also be evaluated.
All trial parts consist of a screening period of up to 42 days, an in-house treatment period (5 days for Part A, 18 days for Part B and 6 days for Part C), a follow-up period with ambulatory visits (3 days for Part A and B and 38 days for Part C) and an ambulatory end-of-trial visit (7 days after (last) dosing for Part A and B and 56 days for Part C) .
The planned starting dose (Part A) is 4 mg NNC0560-0004. Doses will depend on safety results from previous groups. The maximum daily dose will not exceed 420 mg NNC0560-0004 in this trial. In Part C, up to 4 mg will be administered.
NN0560-0004 is being developed by Novo Nordisk for treating the severe forms of non-alcoholic fatty liver disease including non-alcoholic steatohepatitis. In this trial, NNC0560-0004 is administered to humans for the first time.REC name
London - Westminster Research Ethics Committee
REC reference
23/LO/0498
Date of REC Opinion
8 Nov 2023
REC opinion
Further Information Favourable Opinion