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Completed

NCT Number: NCT03010475

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Harrow, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Furosemide

Drug

Oral administration A total of three single doses.

Rosuvastatin

Drug

Oral administration. A total of three single doses.

SNAC

Drug

Oral administration. A total of five single doses.

semaglutide

Drug

Oral administration. Once daily.

Primary outcomes

  1. Area under the furosemide plasma concentration-time curve

    Time frame: day 1, day 7, day 54

    Based on sampling between 0 and 12 hours

  2. Area under the rosuvastatin plasma concentration-time curve

    Time frame: day 2, day 8, day 55

    Based on sampling between 0 and 96 hours

Secondary outcomes

  1. Maximum observed furosemide plasma concentration

    Time frame: day 1, day 7, day 54

  2. Maximum observed rosuvastatin plasma concentration

    Time frame: day 2, day 8, day 55

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 5, 2017
Registry last updated
Dec 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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