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

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ClinicalTrials.gov Identifier: NCT01967589
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : June 20, 2014
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: NNC0113-0987 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation on Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of a Long Acting GLP-1 Analogue (NNC0113-0987) in Healthy Male Subjects
Study Start Date : October 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Experimental: DC (dosing condition)
Escalation design.
Drug: NNC0113-0987
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

Drug: placebo
Once-daily doses for oral administration

Experimental: Oral A
Escalation design. Planned end-dose is 5 mg.
Drug: NNC0113-0987
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

Drug: placebo
Once-daily doses for oral administration

Experimental: Oral B
Escalation design. Planned end-dose is 10 mg.
Drug: NNC0113-0987
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

Drug: placebo
Once-daily doses for oral administration

Experimental: Oral C
Escalation design. Planned end-dose is 20 mg.
Drug: NNC0113-0987
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

Drug: placebo
Once-daily doses for oral administration




Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) recorded [ Time Frame: From the time of first dosing (Day 0) and until completion of the post-treatment follow-up visit (Day 83−97) ]

Secondary Outcome Measures :
  1. Area under the NNC0113-0987 plasma concentration curve [ Time Frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) ]
  2. Maximum observed NNC0113-0987 plasma concentration [ Time Frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) ]
  3. Time to maximum observed NNC0113-0987 plasma concentration [ Time Frame: During a dosing interval (0-24 hours) at steady state (Day 67; Day 68 and Day 69) ]
  4. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70) ]
  5. Change in HbA1C (glycosylated haemoglobin) [ Time Frame: From baseline (Day 0, pre-dose) to after 10 weeks of treatment (Day 70) ]
  6. Change in body weight [ Time Frame: From baseline (Day -1) to after 10 weeks of treatment (Day 70) ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967589


Locations
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United Kingdom
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01967589     History of Changes
Other Study ID Numbers: NN9926-3950
2012-002893-30 ( EudraCT Number )
U1111-1131-8724 ( Other Identifier: WHO )
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: June 20, 2014
Last Verified: June 2014