Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: placebo; Drug: NNC0113-0987

Study type: Interventional

Funder types: Industry

Identifiers

NCT01978613

2013-000188-10 (EudraCT Number)

NN9927-4022

U1111-1138-4595 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.

Enrollment: 100 patients

Sex: Male

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
• Age 18-64 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI): 20.0-29.9 kg/m^2 (both inclusive)

Exclusion criteria

• History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological,dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
• Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
• History of chronic pancreatitis or idiopathic acute pancreatitis
• Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
• Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 5 patient groups

Oral B (DC)

Experimental group

Description:

Escalation design. Planned end dose level is 5 mg alternative dosing condition (fasting for 30 minutes post-dosing)

Treatment:

Drug: NNC0113-0987

Drug: placebo

Oral D

Experimental group

Description:

Escalation design. Planned end dose level is 20 mg standard dosing condition (fasting for 120 minutes post-dosing)

Treatment:

Drug: NNC0113-0987

Drug: placebo

Oral C

Experimental group

Description:

Escalation design. Planned end dose level is 10 mg standard dosing condition (fasting for 120 minutes post-dosing)

Treatment:

Drug: NNC0113-0987

Drug: placebo

Oral B

Experimental group

Description:

Escalation design. Planned end dose level is 5 mg standard dosing condition (fasting for 120 minutes post-dosing)

Treatment:

Drug: NNC0113-0987

Drug: placebo

Oral A

Experimental group

Description:

Escalation design. Planned end dose level is 2.5 mg standard dosing condition (fasting for 120 minutes post-dosing)

Treatment:

Drug: NNC0113-0987

Drug: placebo