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Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT02300844
Recruitment Status : Completed
First Posted : November 25, 2014
Last Update Posted : January 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability and pharmacokinetics of single doses of NNC0174-0833 in normal weight, overweight to obese but otherwise healthy male subjects.

Condition or disease Intervention/treatment Phase
Metabolism and Nutrition Disorder Obesity Drug: NNC0174-0833 Drug: placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigation on Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0174-0833 in Normal Weight, Overweight to Obese But Otherwise Healthy Male Subjects
Actual Study Start Date : December 1, 2014
Actual Primary Completion Date : March 21, 2016
Actual Study Completion Date : March 21, 2016

Arm Intervention/treatment
Experimental: NNC0174-0833 10 mg/mL Drug: NNC0174-0833

Subjects will receive a single s.c. (subcutaneous/under the skin) dose of NNC0174-0833.

Up to nine dose levels of single s.c. doses of NNC0174-0833 are planned to be investigated.


Placebo Comparator: Placebo Drug: placebo
Subjects will receive a single s.c. (subcutaneousl/under the skin) dose.




Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From the time of dosing (Day 1) until completion of the post treatment follow-up visit (Day 43-50) ]

Secondary Outcome Measures :
  1. Area under the NNC0174-0833 plasma concentration-time curve [ Time Frame: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose ]
  2. Maximum concentration of NNC0174-0833 in plasma [ Time Frame: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose ]
  3. Time to maximum concentration of NNC0174-0833 in plasma [ Time Frame: Prior to the initial dose on day 1 and 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 48, 60, 72, 96, 120, 168, 240, 336, 504, and 1008 hours post-dose ]


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Ages Eligible for Study:   22 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal weight, Overweight or obese (Body Mass Index [BMI]) between or equal to 20.0 and 35.0 kg/m^2 but otherwise healthy men
  • Age between or equal to 22 and 64 years at the time of signing informed consent

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 including sleep apnoea, as judged by the investigator
  • Subjects with history of, or presence of, a disease being associated with impaired calcium homeostasis and/or increased bone turnover (e.g. Paget´s disease, osteoporosis)
  • Male subjects of reproductive age who are not using a highly effective physical barrier method of contraception (sexual abstinence, or condom with spermicidal foam/gel/film/cream) combined with a method with Pearl Index less than 1% for their nonpregnant partner(s) (such as implants, injectables, combined oral contraceptives, hormonal intrauterine devices or diaphragm+spermicide, or surgical sterilisation or post-menopausal) and/or who intend to donate sperm in the period from start of Visit 2 up to 3 months following the administration of the investigational medicinal product

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): NCT02300844


Locations
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United States, Kansas
Novo Nordisk Investigational Site
Overland Park, Kansas, United States, 66212
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: NCT02300844     History of Changes
Other Study ID Numbers: NN9838-3993
U1111-1131-7160 ( Other Identifier: WHO )
First Posted: November 25, 2014    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
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Overweight
Nutrition Disorders
Body Weight
Signs and Symptoms