Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects

NCT01967589 | Completed Phase 1

• 3 other identifiers: NN9926-39502012-002893-30U1111-1131-8724
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of multiple doses of a long acting GLP-1 analogue (NNC0113-0987) in healthy male subjects.

Conditions

Diabetes; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of treatment emergent adverse events (TEAEs) recorded

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

Secondary Outcomes (6)

• Area under the NNC0113-0987 plasma concentration 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)

• Time to maximum observed NNC0113-0987 plasma concentration

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

• Change in fasting plasma glucose (FPG)

  From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)

• Change in HbA1C (glycosylated haemoglobin)

  From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70)

Study Arms (4)

DC (dosing condition)

EXPERIMENTAL

Escalation design.

Drug: NNC0113-0987; Drug: placebo

Oral A

EXPERIMENTAL

Escalation design. Planned end-dose is 5 mg.

Drug: NNC0113-0987; Drug: placebo

Oral B

EXPERIMENTAL

Escalation design. Planned end-dose is 10 mg.

Drug: NNC0113-0987; Drug: placebo

Oral C

EXPERIMENTAL

Escalation design. Planned end-dose is 20 mg.

Drug: NNC0113-0987; Drug: placebo

Interventions

NNC0113-0987 DRUG

Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation

DC (dosing condition); Oral A; Oral B; Oral C

placebo DRUG

Once-daily doses for oral administration

DC (dosing condition); Oral A; Oral B; Oral C

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male, who is considered to be generally healthy, based on the medical history, physical examination and the results of vital signs, electrocardiogram (ECG) 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
• BMI (body mass index) 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 (GI), 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 type 2
• History of chronic pancreatitis or idiopathic acute pancreatitis
• Use of prescription or non-prescription medicinal and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
• Subject with previous GI surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Harrow, HA1 3UJ, United Kingdom

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: October 18, 2013
• First Posted: October 23, 2013
• Study Start: October 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

GB (1)