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

Phase 1

Completed

• Conditions: Metabolism and Nutrition Disorder; Obesity
• Interventions: Drug: placebo; Drug: NNC0174-0833

• Registration Number: NCT02300844
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-21
• Study First Submitted QC: 2014-11-21
• Study First Posted: 2014-11-25
• Study Start: 2014-12-01
• Primary Completion: 2016-03-21
• Study Completion: 2016-03-21
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 54

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
NNC0174-0833 10 mg/mL	NNC0174-0833	-

Primary Outcome Measures

Name	Time	Method
Number of treatment emergent adverse events (TEAEs)	From the time of dosing (Day 1) until completion of the post treatment follow-up visit (Day 43-50)

Secondary Outcome Measures

Name	Time	Method
Area under the NNC0174-0833 plasma concentration-time curve	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
Maximum concentration of NNC0174-0833 in plasma	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
Time to maximum concentration of NNC0174-0833 in plasma	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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇺🇸 Overland Park, Kansas, United States