Safety and Tolerability of Liraglutide in Healthy Japanese Volunteers
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01620476
First received: June 13, 2012
Last updated: NA
Last verified: June 2012
History: No changes posted
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Purpose
This trial is conducted in Japan. The aim of this trial is to assess the safety and tolerability of liraglutide in healthy Japanese male subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Healthy |
Drug: liraglutide Drug: placebo |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomised, Double-blind, Single-centre, Placebo-controlled, 21-day Multiple s.c. Doses, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Liraglutide (NNC 90-1170) in Healthy Japanese Male Subjects |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes Medicines
Drug Information available for:
Liraglutide
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Area under the plasma liraglutide curve [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cmax, maximum plasma liraglutide concentration [ Designated as safety issue: No ]
- tmax, time to reach Cmax [ Designated as safety issue: No ]
- Terminal phase elimination rate-constant [ Designated as safety issue: No ]
- t½, terminal elimination half life [ Designated as safety issue: No ]
- 24-hour profiles of serum insulin [ Designated as safety issue: No ]
- 24-hour profiles of serum glucose [ Designated as safety issue: No ]
- 24-hour profiles of plasma glucagon [ Designated as safety issue: No ]
- Adverse events [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | September 2003 |
| Study Completion Date: | March 2004 |
| Primary Completion Date: | March 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 5 mcg/kg |
Drug: liraglutide
5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
|
| Experimental: 10 mcg/kg |
Drug: liraglutide
5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
|
| Experimental: 15 mcg/kg |
Drug: liraglutide
5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily
Drug: placebo
Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
|
Eligibility| Ages Eligible for Study: | 20 Years to 45 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy
- Japanese
- Body mass index (BMI) between 18 and 27 kg/m^2 inclusive
Exclusion Criteria:
- Any clinical laboratory values deviated from the reference range at the laboratory
- Presence of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders
- Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies positive
- History of diabetes, cancer or any clinically significant cardiac, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, dermatological, venereal, haematological, neurological, or psychiatric diseases or disorders.
- History of significant allergy or hypersensitivity
- Known or suspected allergy to trial product or related products.
- History of drug or alcohol abuse
- Smokes more than 15 cigarettes, or the equivalent, per day andis unwilling to refrain from smoking whenever required for the trial procedure
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Public Access to Clinical Trials, Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT01620476 History of Changes |
| Other Study ID Numbers: | NN2211-1551 |
| Study First Received: | June 13, 2012 |
| Last Updated: | June 13, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Glucagon-Like Peptide 1 Incretins Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013