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Research Study to Investigate How a Study Medicine (NNC9204- 1177) Affects Blood Levels of Other Medicines in Healthy People

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ClinicalTrials.gov Identifier: NCT04059367
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : September 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
The study looks at how the study medicine (NNC9204-1177) affects other medicines in the body. Participants will get the study medicine and 5 other medicines which have all been approved by the authorities. Participants will get 1 injection of the study medicine each week for 11 weeks. The study medicine is injected under the skin in the stomach area. All injections will be given by study staff. Participants will get 5 medicines as tablets, capsules or syrup to be taken with water at the beginning of the study and after 10 weeks of treatment with the study medicine. The study will last for about 4 months. Participants will have 14 visits to the clinic with the study staff and study doctor. Participants will have blood draws and 2 different kinds of electrocardiograms taken during the study. They will be asked about your mental health. People who use any medication, including herbal products, cannot take part in the study. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period or if they use birth control pills or other hormonal birth control products.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Overweight Obesity Drug: NNC9204-1177 Drug: Cocktail of 5 already approved drugs Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-sequence, cross-over drug interaction trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-sequence, Crossover Trial Investigating the Influence of NNC9204-1177 on Pharmacokinetics of Index Substrates for Cytochrome P450 Enzymes
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : January 13, 2020
Estimated Study Completion Date : January 13, 2020

Arm Intervention/treatment
Experimental: NNC9204-1177 and cocktail of approved drugs Drug: NNC9204-1177
Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks

Drug: Cocktail of 5 already approved drugs
5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study




Primary Outcome Measures :
  1. Area under the plasma concentration-time curve extrapolated to infinity of the caffeine [ Time Frame: From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng*h/mL

  2. Area under the plasma concentration-time curve extrapolated to infinity of the omeprazole [ Time Frame: From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng*h/mL

  3. Area under the plasma concentration-time curve extrapolated to infinity of the midazolam [ Time Frame: From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng*h/mL

  4. Area under the plasma concentration-time curve extrapolated to infinity of the s-warfarin [ Time Frame: From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng*h/mL

  5. Area under the plasma concentration-time curve extrapolated to infinity of the dextromethorphan [ Time Frame: From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng*h/mL


Secondary Outcome Measures :
  1. Maximum observed plasma caffeine concentration after a single dose [ Time Frame: From 0 to 24 hours after a single dose of caffeine without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng/mL

  2. Maximum observed plasma omeprazole concentration after a single dose [ Time Frame: From 0 to 8 hours after a single dose of omeprazole without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng/mL

  3. Maximum observed plasma s-warfarin concentration after a single dose [ Time Frame: From 0 to 168 hours after a single dose of warfarin without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng/mL

  4. Maximum observed plasma midazolam concentration after a single dose [ Time Frame: From 0 to 12 hours after a single dose of midazolam without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng/mL

  5. Maximum observed plasma dextromethorphan concentration after a single dose [ Time Frame: From 0 to 72 hours after a single dose of dextromethorphan without NNC9204-1177 exposure (administered on Visit 2, Day 1) and at NNC9204-1177 steady state (administered on Visit 12, Day 78) ]
    ng/mL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female, aged 18-60 years (both inclusive) at the time of signing informed consent.
  • Body mass index (BMI) between 23.0 and 29.9 kg/m^2 (both inclusive) at screening.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG) and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

  • Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method (intra-uterine device (IUD), vasectomised partner or sexual abstinence)
  • Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol.
  • Use of prescription medicinal products or non-prescription drugs, except for IUDs, within 14 days prior to the day of screening.
  • Use of any herbal medicine known to interfere with the metabolic CYP pathways, such as Hypericum (St. John's Wort), ginseng, garlic, milk thistle, and echinaceae, within 14 days prior to the day of screening.

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): NCT04059367


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United States, Texas
Novo Nordisk Investigational Site Recruiting
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04059367     History of Changes
Other Study ID Numbers: NN9277-4555
U1111-1232-7100 Trial ( Other Identifier: World Health Organization (WHO) )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: September 4, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Overweight
Body Weight
Signs and Symptoms