A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0148-0000-0362 in Healthy Subjects

Novo Nordisk A/S83 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to investigate the safety, tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect of drug) of NNC 0148-0000-0362 as tablets in healthy volunteers. The trial consists of two parts. In part 1, single escalating doses of NNC 0148-0000-0362, placebo or insulin glargine is given. In part 2, subjects will receive single doses of NNC 0148-0000-0362 administered orally or intravenously.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2 Healthy

Interventions

Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group

insulin glargineDRUG

As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group

placeboDRUG

Subjects will receive a single dose of oral placebo within each dose group

NNC 0148-0000-0362DRUG

Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period

NNC 0148-0000-0362DRUG

Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period

NNC 0148-0000-0362DRUG

Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index 18-28 kg/m\^2 (both inclusive) * Subject who is considered to be healthy 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 Exclusion Criteria: * Known or suspected hypersensitivity to trial products or related products * Previous participation in this trial. Participation is defined as randomised * Presence of clinically significant acute gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to dosing, as judged by the investigator * Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol

Locations (1)

Unnamed facility

Neuss, Germany

Outcomes

Primary Outcomes

Number of adverse events

Time frame: Recorded from trial product administration and until completion of Sub-visit G (i.e. Day 13) of the dosing visit

Secondary Outcomes

Area under the serum insulin concentration-time curve (with Trial part 1)

Time frame: From 0 to 288 hours after a single oral dose of NNC 0148-0000-0362 or a single subcutaneous (s.c.) dose of insulin glargine, respectively

Area under the glucose infusion rate (GIR)-time curve (Trial part 1)

Time frame: From 0 to 24 hours after a single oral dose of NNC 0148-0000-0362 or a single s.c. dose of insulin glargine, respectively

Area under the serum insulin concentration-time curve (Trial part 2)

Time frame: From 0 hours to infinity after a single dose of NNC 0148-0000-0362 administered orally as 1 and 3 tablets and intravenously, respectively

Data from ClinicalTrials.gov

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