HealthyPhase 1NCT02911870
A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects.
A Phase 1 study testing SNAC and Moxifloxacin in people with Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SNAC and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteGermany
- Study dates
- 23 Sep 2016to 11 May 2017
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 18.5-28.0 kg/m^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs and clinical laboratory tests performed during the screening visit, as judged by the investigator
- Normal electrocardiogram (ECG) at screening or minor findings considered not clinically significant, as judged by the investigator
Who cannot join
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per week), or subject smoking equal to or less than 5 cigarettes or the equivalent per week who is not able or willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to each dosing and during the in-patient periods
- 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
- Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects
- Conditions
- Healthy
- Being tested
- SNAC, Placebo, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNACDrug
Oral administration
PlaceboDrug
Oral administration
MoxifloxacinDrug
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Part A, SNAC | Experimental | Single dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants. Receives: Drug: SNAC |
| Part A, placebo | Placebo comparator | Single dose at corresponding dose levels. Receives: Drug: Placebo |
| Part B, SNAC, Placebo, Moxifloxacin | Experimental | Subjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg. Receives: Drug: SNAC; Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events
PART A
Measured: From dosing (day 1) to follow-up (days 8-11)
The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF)
PART B
Measured: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours
Secondary outcomes (4)
Maximum observed SNAC plasma concentration
PART A
Measured: From 0 to 12 hours
Trial population-specific (accounted for individual subject levels) corrected QT interval (QTcP)
PART B
Measured: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8 and 12 hours
Area under the SNAC plasma concentration time curve
PART B
Measured: From 0 to 12 hours
Maximum observed SNAC plasma concentration
PART B
Measured: From 0 to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start23 Sep 2016
- Primary completion4 May 2017
- Study completion11 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911870
- Sponsor's protocol ID
- NN9924-4247
- Other IDs
- 2015-002418-54, U1111-1170-7054, 2015
- Status last verified
- Jan 2018
- First submitted
- 20 Sep 2016
- Last updated
- 12 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Granhall C, Baekdal TA, Breitschaft A, Sondergaard FL, Anderson TW, Thomsen M. Absence of QTc Prolongation with Sodium N-(8-[2-Hydroxybenzoyl] Amino) Caprylate (SNAC), an Absorption Enhancer Co-Formulated with the GLP-1 Analogue Semaglutide for Oral Administration. Diabetes Ther. 2021 Sep;12(9):2599-2610. doi: 10.1007/s13300-021-01106-x. Epub 2021 Jul 28.
PubMed 34319564
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Thorough QTc Trial Evaluating the Effect of SNAC on Cardiac Repolarisation in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02911870
- Acronym / sponsor ID
- NN9924-4247
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 11 May 2017 (actual)
- First posted
- 22 Sep 2016 (estimated)
- 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.
This trial is conducted in Europe. The aim of this trial is to evaluate the effect of SNAC on cardiac repolarisation in healthy male subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A, SNAC | Experimental | Drug: SNACSingle dose of 1.2mg, 2.4mg or 3.6mg increasing for each cohort of trial participants. |
| Part A, placebo | Placebo comparator | Drug: PlaceboSingle dose at corresponding dose levels. |
| Part B, SNAC, Placebo, Moxifloxacin | Experimental | Drug: SNAC, Drug: Placebo, Drug: MoxifloxacinSubjects will receive 4 different treatments in random order. SNAC dose between 1.2-3.6 mg, Placebo in two different periods, moxifloxacin 400mg. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male aged 18-55 years (both inclusive) at the time of signing informed consent
- Body mass index (BMI) between 18.5-28.0 kg/m^2 (both inclusive)
- Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs and clinical laboratory tests performed during the screening visit, as judged by the investigator
- Normal electrocardiogram (ECG) at screening or minor findings considered not clinically significant, as judged by the investigator
Key exclusion criteria (4 listed)
- Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per week), or subject smoking equal to or less than 5 cigarettes or the equivalent per week who is not able or willing to refrain from smoking and use of nicotine substitute products within 48 hours prior to each dosing and during the in-patient periods
- 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
- Sitting blood pressure at screening (after resting for at least 5 minutes) outside the range of 90-139 mmHg for systolic or 50-89 mmHg for diastolic
- 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)
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 |
|---|---|---|
| SNACOral administration | Drug | Part A, SNAC, Part B, SNAC, Placebo, Moxifloxacin |
| PlaceboOral administration | Drug | Part A, placebo, Part B, SNAC, Placebo, Moxifloxacin |
| MoxifloxacinOral administration | Drug | Part B, SNAC, Placebo, Moxifloxacin |
Primary outcome
Number of treatment emergent adverse events
Time frame: From dosing (day 1) to follow-up (days 8-11)
PART A
The co-primary endpoints are Fridericia heart rate corrected QT interval (QTcF)
Time frame: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8, and 12 hours
PART B
4 secondary outcomes
Maximum observed SNAC plasma concentration
Time frame: From 0 to 12 hours
Trial population-specific (accounted for individual subject levels) corrected QT interval (QTcP)
Time frame: At 10, 20, 30, 40, 50 minutes, 1, 1.5, 2, 2.5, 3, 4, 5, 8 and 12 hours
Area under the SNAC plasma concentration time curve
Time frame: From 0 to 12 hours
Maximum observed SNAC plasma concentration
Time frame: From 0 to 12 hours
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 Jan 2018.
- Derived from this study: PubMed 34319564Granhall C, Baekdal TA, Breitschaft A, Sondergaard FL, Anderson TW, Thomsen M. Absence of QTc Prolongation with Sodium N-(8-[2-Hydroxybenzoyl] Amino) Caprylate (SNAC), an Absorption Enhancer Co-Formulated with the GLP-1 Analogue Semaglutide for Oral Administration. Diabetes Ther. 2021 Sep;12(9):2599-2610. doi: 10.1007/s13300-021-01106-x. Epub 2021 Jul 28.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SNAC and Moxifloxacin in people with Healthy, run by Novo Nordisk A/S at 1 site in Germany.
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 4 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 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Number of treatment emergent adverse events (time frame: From dosing (day 1) to follow-up (days 8-11)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02911870, which also lists 1 linked publication.
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 Jan 2018.