A Bioequivalence Study of Two Formulations of Oral Semaglutide in Healthy Participants
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 546
- Locations
- 3
- Primary Endpoint
- AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
Study Overview
Brief Summary
The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood in two different tablet versions of Semaglutide. The study will consist of 3 groups and the treatment the participants will get is dependent on the group the participants will be enrolled in.
The participants in group 1 will receive treatment for 22 weeks, group 2 for 21 weeks and group 3 for 20 weeks.
The study will last up to 29 to 31 weeks for each participant. This includes a screening period (up to 4 weeks), a dose escalation period (up to 2 weeks), a treatment period (20 weeks) and a follow-up period (5 weeks after the last dose).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Male or female, aged 18-64 years (both inclusive) at the time of signing informed consent. - Body mass index (BMI) between 21.0 and 32.0 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
- •HbA1c equal to or greater than 6.5 % (48 mmol/mol) at screening.
- •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 within 48 hours prior to and during the inpatient periods
- •Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- •History(a) 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(a).
- •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma(a).
- •As declared by the participant or reported in the medical records
Arms & Interventions
Group 2 Sequence 2
Crossover arm
Intervention: Semaglutide D Dose 1 (Drug)
Group 3 Sequence 2
Crossover arm
Intervention: Semaglutide D Dose 1 (Drug)
Group 1 Sequence 1
Crossover arm
Intervention: Semaglutide D Dose 1 (Drug)
Group 1 Sequence 1
Crossover arm
Intervention: Semaglutide D Dose 2 (Drug)
Group 1 Sequence 1
Crossover arm
Intervention: Semaglutide D Dose 3 (Drug)
Group 1 Sequence 1
Crossover arm
Intervention: Semaglutide Dose 6 (Drug)
Group 1 Sequence 2
Crossover arm
Intervention: Semaglutide D Dose 3 (Drug)
Group 1 Sequence 2
Crossover arm
Intervention: Semaglutide Dose 4 (Drug)
Group 1 Sequence 2
Crossover arm
Intervention: Semaglutide Dose 5 (Drug)
Group 1 Sequence 2
Crossover arm
Intervention: Semaglutide Dose 6 (Drug)
Group 2 Sequence 1
Crossover arm
Intervention: Semaglutide D Dose 1 (Drug)
Group 2 Sequence 1
Crossover arm
Intervention: Semaglutide D Dose 2 (Drug)
Group 2 Sequence 1
Crossover arm
Intervention: Semaglutide Dose 4 (Drug)
Group 2 Sequence 1
Crossover arm
Intervention: Semaglutide Dose 5 (Drug)
Group 2 Sequence 2
Crossover arm
Intervention: Semaglutide D Dose 2 (Drug)
Group 2 Sequence 2
Crossover arm
Intervention: Semaglutide Dose 4 (Drug)
Group 2 Sequence 2
Crossover arm
Intervention: Semaglutide Dose 5 (Drug)
Group 3 Sequence 1
Crossover arm
Intervention: Semaglutide D Dose 1 (Drug)
Group 3 Sequence 1
Crossover arm
Intervention: Semaglutide Dose 4 (Drug)
Group 3 Sequence 2
Crossover arm
Intervention: Semaglutide Dose 4 (Drug)
Outcomes
Primary Outcomes
AUC0-24h,semaglutide,SS Area under the semaglutide plasma concentration-time curve during a dosing interval at steady state (SS)
Time Frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
h∙nmol/L
Cmax,0-24h.semaglutide,SS Maximum semaglutide plasma concentration at steady state
Time Frame: 24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.
nmol/L
Secondary Outcomes
- tmax,0-24h,semaglutide,SS Time to maximum semaglutide plasma contraction at steady state(24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.)
- Ctau,24h,semaglutide,SS Semaglutide plasma concentration 24 hours after last dose at steady state(24 hours after the dosing of oral semaglutide on days 35/42/49, 70/77/84, 105/112/119 and 140/147/154.)