A Research Study Investigating How Semaglutide and Dapagliflozin Act in Your Body When Dosed in One Tablet

Overview

This study will test how the active substances semaglutide and dapagliflozin act in the body (in terms of their levels in the blood), when they are taken in the form of a combination preparation (a tablet with a fixed dose combination) compared to when oral semaglutide and dapagliflozin are given alone.The study will consist of 2 parts. Part 1 will compare semaglutide to the fixed dose combination tablet (semaglutide/dapagliflozin) and part 2 will compare dapagliflozin to the fixed dose combination tablet (semaglutide/dapagliflozin). Participants will take part in either part 1 or part 2.

Full Title of Study: “A Study Comparing Exposure of Semaglutide and Dapagliflozin Dosed Orally as Mono-components Versus in a Fixed-dose Combination”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 29, 2023

Interventions

  • Drug: Semaglutide
    • Tablet given orally
  • Drug: Dapagliflozin
    • Tablet given orally
  • Drug: Semaglutide/dapagliflozin
    • Tablet given orally

Arms, Groups and Cohorts

  • Experimental: Part 1 sequence A
    • Semaglutide followed by Semaglutide/dapagliflozin
  • Experimental: Part 1 sequence B
    • Semaglutide/dapagliflozin followed by Semaglutide
  • Experimental: Part 2 sequence A
    • Dapagliflozin followed by Semaglutide/dapagliflozin
  • Experimental: Part 2 sequence B
    • Semaglutide/dapagliflozin followed by dapagliflozin

Clinical Trial Outcome Measures

Primary Measures

  • AUC0-24h,sema,ss: area under the semaglutide plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
    • Time Frame: From 0 to 24 hours on day 49 and 84 in Part 1
    • measured in h*nmol/L
  • AUC0-24h,dapa,ss: area under the dapagliflozin plasma concentration-time curve during a dosing interval (0 to 24 hours) at steady state
    • Time Frame: From 0 to 24 hours on day 49 and 98 in Part 2
    • measured inh*ng/mL

Secondary Measures

  • Cmax,sema,ss: maximum observed semaglutide plasma concentration during a dosing interval (0 to 24 hours) at steady state)
    • Time Frame: From 0 to 24 hours on day 49 and 84 in Part 1
    • measured in nmol/L
  • Cmax,dapa,ss: maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state
    • Time Frame: From 0 to 24 hours on day 49 and 98 in Part 2
    • measured in ng/mL
  • tmax,sema,ss: time to maximum observed semaglutide plasma concentration during a dosing interval (0 to 24) at steady state
    • Time Frame: From 0 to 24 hours on day 49 and 84 in Part 1
    • measured in hours
  • tmax,dapa,ss: time to maximum observed dapagliflozin plasma concentration during a dosing interval (0 to 24 hours) at steady state
    • Time Frame: From 0 to 24 hours on day 49 and 98 in Part 2
    • measured in hours

Participating in This Clinical Trial

Inclusion Criteria

  • Male or female – Aged 18-64 years (both inclusive) at the time of signing informed consent. – Body mass index between 20.0 and 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, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria:

  • Participation (i.e., signed informed consent) in any other interventional, clinical study within 30 days (or 5 half-lifes of the investigational medicinal product, whichever is longer) before randomisation. – Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly-effective contraceptive method. – Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. – Use of tobacco and nicotine products, defined as any of the below: – Smoking more than 5 cigarettes or the equivalent per day – Not willing to refrain from smoking and use of nicotine substitute products during the in-house periods – Blood donation, plasma donation or blood draw, defined as any of the below: – In excess of 400 mL within the past 90 days prior to the day of screening – In excess of 50 mL within the past 30 days prior to the day of screening – History of major surgical procedures involving the stomach potentially affecting absorption of trial products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery) or current presence of gastrointestinal implant. – Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 64 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Transparency (dept. 2834), Study Director, Novo Nordisk A/S
  • Overall Contact(s)
    • Novo Nordisk, (+1) 866-867-7178, clinicaltrials@novonordisk.com

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