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A Trial Investigating the Effect of Oral Semaglutide on the Pharmacokinetics of Furosemide and Rosuvastatin in Healthy Subjects

NCT ID: NCT03010475

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-05

Study Completion Date

2017-08-09

Brief Summary

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This trial is conducted in Europe. Tha aim of this trial is to investigate the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects.

Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Furosemide/Rosuvastatin/SNAC/Semaglutide

Group Type EXPERIMENTAL

Furosemide

Intervention Type DRUG

Oral administration A total of three single doses.

Rosuvastatin

Intervention Type DRUG

Oral administration. A total of three single doses.

SNAC

Intervention Type DRUG

Oral administration. A total of five single doses.

Semaglutide

Intervention Type DRUG

Oral administration. Once daily.

Interventions

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Furosemide

Oral administration A total of three single doses.

Intervention Type DRUG

Rosuvastatin

Oral administration. A total of three single doses.

Intervention Type DRUG

SNAC

Oral administration. A total of five single doses.

Intervention Type DRUG

Semaglutide

Oral administration. Once daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, aged 18-65 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 20.0-29.9 kg/m\^2 (both inclusive)
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiography and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria

* Smoker (defined as a subject who is smoking at least one cigarette or the equivalent per day)
* Any blood draw in excess of 25 mL in the past month, or donation of blood or plasma in excess of 400 mL within the 3 months preceding screening
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Have personal or family history of myopathy
* Previous history of muscular toxicity with another HMG-CoA reductase inhibitor or fibrate
* Thyroid-Stimulating Hormone outside lower limit of normal minus 10 percent and upper limit of normal plus 10 percent
* Creatine kinase above 5 x upper limit of normal
* Asian subject
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novo Nordisk Investigational Site

Harrow, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Jordy AB, Albayaty M, Breitschaft A, Anderson TW, Christiansen E, Houshmand-Oregaard A, Manigandan E, Baekdal TA. Effect of Oral Semaglutide on the Pharmacokinetics of Levonorgestrel and Ethinylestradiol in Healthy Postmenopausal Women and Furosemide and Rosuvastatin in Healthy Subjects. Clin Pharmacokinet. 2021 Sep;60(9):1171-1185. doi: 10.1007/s40262-020-00976-x.

Reference Type DERIVED
PMID: 33782832 (View on PubMed)

Other Identifiers

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2015-003908-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1173-8618

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4250

Identifier Type: -

Identifier Source: org_study_id