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

NCT01978613 | Completed Phase 1

• 3 other identifiers: NN9927-40222013-000188-10U1111-1138-4595
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events recorded

  From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)

Secondary Outcomes (3)

• Number of hypoglycaemic episodes

  From the time of first dosing (day 0) and until completion of the post-treatment follow-up visit (day 83-97)

• Area under the NNC0113-0987 plasma concentration time curve

  During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)

• Maximum observed NNC0113-0987 plasma concentration

  During a dosing interval (0-24 hours) at steady state (day 67, day 68 and day 69)

Study Arms (5)

Oral B (DC)

EXPERIMENTAL

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

Drug: NNC0113-0987; Drug: placebo

Oral D

EXPERIMENTAL

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

Drug: NNC0113-0987; Drug: placebo

Oral C

EXPERIMENTAL

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

Drug: NNC0113-0987; Drug: placebo

Oral B

EXPERIMENTAL

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

Drug: NNC0113-0987; Drug: placebo

Oral A

EXPERIMENTAL

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

Drug: NNC0113-0987; Drug: placebo

Interventions

NNC0113-0987 DRUG

Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.

Oral A; Oral B; Oral B (DC); Oral C; Oral D

placebo DRUG

Tablets for one-daily oral administration.

Oral A; Oral B; Oral B (DC); Oral C; Oral D

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Berlin, 14050, Germany

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2013
• First Posted: November 7, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: June 30, 2014

Record last verified: 2014-06

Locations

DE (1)