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A Research Study of a New Medicine NNC0519-0130 in Japanese and Non-Japanese Men

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05870670
Collaborator
(none)
70
Enrollment
1
Location
2
Arms
6
Anticipated Duration (Months)
11.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes. This study, will look into how safe the new medicine NNC0519-0130 is, and we will measure its concentrations in the blood and look at its effects. This study will last for a maximum of 19 weeks and Japanese and Non-Japanese male participants will be included.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose:
Treatment
Official Title:
Investigation of Pharmacokinetics, Safety, and Tolerability of Multiple Oral and Subcutaneous Doses of NNC0519-0130 in Japanese and Non-Japanese Male Participants
Anticipated Study Start Date :
May 15, 2023
Anticipated Primary Completion Date :
Oct 10, 2023
Anticipated Study Completion Date :
Nov 14, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Oral Study Part: NNC0519-0130 or Placebo

Escalating multiple doses of NNC0519-0130 or placebo administered orally.

Drug: NNC0519-0130
Administered orally or subcutaneously.

Drug: Placebo
Administered orally or subcutaneously.
Experimental: S.C. Study Part: NNC0519-0130 or Placebo

Escalating multiple doses of NNC0519-0130 or placebo administered subcutaneously.

Drug: NNC0519-0130
Administered orally or subcutaneously.

Drug: Placebo
Administered orally or subcutaneously.

Outcome Measures

Primary Outcome Measures

  1. AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period in the Oral Study Part [From pre-dose until 24 hours post-dose relative to last dose in each treatment period]

    Measured in hours*nanomoles per liter (h*nmol/L).

  2. AUC0-24h,0130, SS: Area Under the NNC0519-0130 Plasma Concentration-Time Curve After the Last Dose in Each Treatment Period in the S.C. Study Part [From pre-dose until 24 hours post-dose relative to last dose in each treatment period]

    Measured in h*nmol/L.

Secondary Outcome Measures

  1. Cmax,0130, SS: Maximum Plasma Concentration of NNC0519-0130 After the Last Dose in Each Treatment Period in the Oral Study Part [From pre-dose until 24 hours post-dose relative to last dose in each treatment period]

    Measured in nanomoles per liter (nmol/L).

  2. Cmax,0130, SS: Maximum Plasma Concentration of NNC0519- 0130 After the Last Dose in Each Treatment Period in the S.C. Study Part [From pre-dose until 24 hours post-dose relative to last dose in each treatment period]

    Measured in nmol/L.

  3. Number of Treatment Emergent Adverse Events (TEAE)s in the Oral Study Part [From time of dosing (day 1) until completion of the follow-up visit (day 105)]

    Measured as number of events.

  4. Number of TEAEs in the S.C. Study Part [From time of dosing (day 1) until completion of the follow-up visit (day 105)]

    Measured as number of events.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Body mass index (BMI) between 23.0 kilogram per meter square (kg/m2) and 39.9 kg/m2 (both inclusive) at screening with a minimum weight of 50 kilogram (kg). Overweight should be due to excess adipose tissue, as judged by the investigator.

  • Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

  • For Japanese participants: Both parents of Japanese descent.

  • For non-Japanese participants in the oral study part: Both parents of non-Japanese descent. Minimum 60% of participants should have parents of Caucasian descent while a maximum of 40% can have parents of Hispanic or African descent.

  • For non-Japanese participants in the s.c. study part: Both parents of Caucasian descent.

Exclusion Criteria:

  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

  • Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

  • Glycosylated haemglobin (HbA1c) greater than or equal to 6.5 percent (48 millimoles per mole [mmol/mol]) at screening.

  • Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, ibuprofen, acetylsalicylic acid (ASA), and domperidon, or topical medication not reaching systemic circulation, within 14 days before screening.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Tokyo Japan 130-0004

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT05870670
Other Study ID Numbers:
  • NN9541-4921
  • U1111-1283-0710
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of May 23, 2023