A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
NCT05129891
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Novo Nordisk A/S
Start date
2021-11-03
Number of sites
- Summary
- In this study, four new tablet versions of two compounds will be investigated. The aim of this study is to investigate the amount of the active ingredient and helping agent in the blood after doses of four different tablet versions. The tablet versions, participants will receive, i.e. the treatment arm participants will be assigned to, is decided by chance. Participants will receive one treatment for 10 days in the first period. For the second period, directly following, participants will receive a different treatment for five more days. The study can last for up to approximately 10 weeks for each participant. This includes a screening period (up to 3 weeks), two treatment periods (together a total of 15 days) and a follow-up visit (5 weeks after the last dosing)
- Short title
- A Research Study Looking at New Protein-based Tablets in Healthy Male Participants
- Official title
- A Study Investigating Pharmacokinetic Properties When Dosing Different Formulations of Oral Peptide Therapeutics in Healthy Male Participants
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2023-05-04
- First posted
- 2021-11-22
- Registry last updated
- 2024-05-29
- Primary completion date
- 2023-02-26
- Start date
- 2021-11-03
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05129891
- ClinicalTrials.gov ID
- NCT05129891
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
AUC0-24h,API,day10; area under the API plasma concentration-time curve from 0 to 24 hours after the 10th dose
Timeframe: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
h \* nmol/L
Cmax,API,day10; maximum observed plasma concentration of API after the 10th dose
Timeframe: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
nmol/L
tmax, API,day10; time from the 10th dose to maximal observed plasma concentration of API
Timeframe: From pre-dose PK sample (0 hours) at day 10 to PK sample 24 hours after dose administration
hours
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- Male.
- Aged 18-55 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.
- Known or suspected hypersensitivity to study interventions or related products.
- Use of prescription medicinal products or non-prescription drugs (including herbal products and vaccines), except routine vitamins and topical medications not reaching the systemic circulation, within 14 days prior to the day of screening.
- Any disorder which in the investigator's opinion might jeopardise participant safety or compliance with the protocol.
- Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
- History (as declared by the participant or reported in the medical records) of major surgical procedures involving the stomach potentially affecting absorption of study products (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
Sources for eligibility
- Altasciences Company Inc.Montreal, Canada
- Parexel International GmbHBerlin, Germany
Sources for sites
- 2021-001452-34
- U1111-1266-0672
Sources for references