Healthy Volunteers; High CholesterolPhase 1NCT05333107
A Research Study Looking at New Protein-based Tablets in Healthy Men - Oral Formulation II
A Phase 1 study testing NNC0385-0434 G, NNC0385-0434 F and NNC0385-0434 B in people with Healthy Volunteers; High Cholesterol, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Read more about this study
- Who is it for?
- Ages 18 to 64 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers; High Cholesterol
- What is being tested?
- NNC0385-0434 G, NNC0385-0434 F and NNC0385-0434 B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Apr 2022to 23 Sep 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 20.0 and 32.0 kilogram per meter square (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
Who cannot join
- 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 of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Altasciences
Cypress, California, 90630
Altasciences Clinical Los Angeles, Inc.
Los Angeles, California, 90630
About this study
Official title: A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II
In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.
- Conditions
- Healthy Volunteers; High Cholesterol
- Being tested
- NNC0385-0434 G, NNC0385-0434 F, NNC0385-0434 B
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0385-0434 GDrug
Participants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
NNC0385-0434 FDrug
Participants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
NNC0385-0434 BDrug
Participants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2).
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1 | Experimental | Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). Receives: Drug: NNC0385-0434 G; Drug: NNC0385-0434 B |
| Sequence 2 | Experimental | Participants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). Receives: Drug: NNC0385-0434 G; Drug: NNC0385-0434 F |
| Sequence 3 | Experimental | Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). Receives: Drug: NNC0385-0434 F; Drug: NNC0385-0434 B |
| Sequence 4 | Experimental | Participants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). Receives: Drug: NNC0385-0434 G; Drug: NNC0385-0434 F |
| Sequence 5 | Experimental | Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). Receives: Drug: NNC0385-0434 G; Drug: NNC0385-0434 B |
| Sequence 6 | Experimental | Participants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). Receives: Drug: NNC0385-0434 F; Drug: NNC0385-0434 B |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
Measured in h * nmol/L
Measured: From 0 to 24 hours after dose administration on visit 2, day 10
Secondary outcomes (2)
Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434
Measured in nmol/L
Measured: From 0 to 24 hours after dose administration on visit 2, day 10
tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434
Measured in hours
Measured: From 0 to 24 hours after dose administration on visit 2, day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start12 Apr 2022
- Primary completion22 Jul 2022
- Study completion23 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers; High CholesterolStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency dept. 2834, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333107
- Sponsor's protocol ID
- NN9501-4869
- Other IDs
- U1111-1271-3953
- Status last verified
- Jul 2024
- First submitted
- 11 Apr 2022
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Investigating the Pharmacokinetic Properties When Dosing Different Formulations of NNC0385-0434 to Healthy Male Participants - Oral Formulation II
- ClinicalTrials.gov ID
- NCT05333107
- Acronym / sponsor ID
- NN9501-4869
- Conditions
- Healthy Volunteers; High Cholesterol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 23 Sep 2022 (actual)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the study drug 'NNC0385-0434' will be tested in 3 different tablet formulations. These formulations are being tested for the treatment of hypercholesterolemia (high cholesterol). Participants will only receive 2 of the 3 tablet formulations. The treatments participants get are decided by chance. Participants will receive 1 formulation for 10 days (first treatment period) and the other formulation for 5 days (second treatment period). The study will last up to 96 days. Only men can participate in this clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Sequence 1 | Experimental | Drug: NNC0385-0434 G, Drug: NNC0385-0434 BParticipants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). |
| Sequence 2 | Experimental | Drug: NNC0385-0434 G, Drug: NNC0385-0434 FParticipants will receive oral dose of NNC0385-0434 G tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). |
| Sequence 3 | Experimental | Drug: NNC0385-0434 F, Drug: NNC0385-0434 BParticipants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 B tablet orally in the 5-day treatment period (period 2). |
| Sequence 4 | Experimental | Drug: NNC0385-0434 G, Drug: NNC0385-0434 FParticipants will receive oral dose of NNC0385-0434 F tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). |
| Sequence 5 | Experimental | Drug: NNC0385-0434 G, Drug: NNC0385-0434 BParticipants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 G tablet orally in the 5-day treatment period (period 2). |
| Sequence 6 | Experimental | Drug: NNC0385-0434 F, Drug: NNC0385-0434 BParticipants will receive oral dose of NNC0385-0434 B tablet for the initial 10-day treatment period (period 1) and the NNC0385-0434 F tablet orally in the 5-day treatment period (period 2). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- Aged 18-64 years (both inclusive) at the time of signing informed consent
- Body mass index between 20.0 and 32.0 kilogram per meter square (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
Key exclusion criteria (5 listed)
- 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 of major surgical procedures involving the stomach potentially affecting absorption of study products (example: subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0385-0434 GParticipants will receive oral dose of NNC0385-0434 G tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2). | Drug | Sequence 1, Sequence 2, Sequence 4, Sequence 5 |
| NNC0385-0434 FParticipants will receive oral dose of NNC0385-0434 F tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2). | Drug | Sequence 2, Sequence 3, Sequence 4, Sequence 6 |
| NNC0385-0434 BParticipants will receive oral dose of NNC0385-0434 B tablet either for the initial 10-day treatment period (period 1) or 5-day treatment period (period 2). | Drug | Sequence 1, Sequence 3, Sequence 5, Sequence 6 |
Primary outcome
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval
Time frame: From 0 to 24 hours after dose administration on visit 2, day 10
Measured in h * nmol/L
2 secondary outcomes
Cmax,NNC0385-0434,day10; maximum observed plasma concentration of NNC0385-0434
Time frame: From 0 to 24 hours after dose administration on visit 2, day 10
tmax,NNC0385-0434,day10; time from dose administration to maximum observed plasma concentration of NNC0385- 0434
Time frame: From 0 to 24 hours after dose administration on visit 2, day 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Transparency dept. 2834 study director
Novo Nordisk A/S
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0385-0434 G, NNC0385-0434 F and NNC0385-0434 B in people with Healthy Volunteers; High Cholesterol, run by Novo Nordisk A/S at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-24h,NNC0385-0434,day10; area under the plasma concentrationtime curve during a dosing interval (time frame: From 0 to 24 hours after dose administration on visit 2, day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.