NCT02300844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 21, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2016

Completed
Last Updated

January 24, 2018

Status Verified

January 1, 2018

Enrollment Period

1.3 years

First QC Date

November 21, 2014

Last Update Submit

January 23, 2018

Conditions

Metabolism and Nutrition DisorderObesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Study Arms (2)

NNC0174-0833 10 mg/mL

EXPERIMENTAL
Drug: NNC0174-0833

Placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

NNC0174-0833DRUG

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.

NNC0174-0833 10 mg/mL
placeboDRUG

Subjects will receive a single s.c. (subcutaneousl/under the skin) dose.

Placebo

Eligibility Criteria

Age22 Years - 64 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Overland Park, Kansas, 66212, United States

Location

Related Links

MeSH Terms

Conditions

Nutrition DisordersObesity

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesOverweightOvernutritionBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

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

November 21, 2014

First Posted

November 25, 2014

Study Start

December 1, 2014

Primary Completion

March 21, 2016

Study Completion

March 21, 2016

Last Updated

January 24, 2018

Record last verified: 2018-01

Locations

US(1)