DiabetesPhase 1NCT02243098
Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects
A Phase 1 study testing semaglutide, digoxin and atorvastatin in people with Diabetes and Healthy, run by Novo Nordisk A/S at 1 site in Germany.
Trial summary
The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- What is being tested?
- semaglutide, digoxin and atorvastatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteGermany
- Study dates
- 16 Sep 2014to 7 Apr 2015
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female, age between 18 and 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)
Who cannot join
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control throughout the trial including the 5 weeks follow-up period. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal supplements, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (first dose administration)
- History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
- History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
- Smoking in the last 3 months prior to screening or a positive nicotine test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects
The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.
- Being tested
- semaglutide, digoxin, atorvastatin
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semaglutideDrug
Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.
digoxinDrug
Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.
atorvastatinDrug
Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Not described Receives: Drug: semaglutide; Drug: digoxin; Drug: atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the atorvastatin plasma concentration-time curve
Measured: From time 0 to 72 hours after a single dose
Area under the digoxin plasma concentration-time curve
Measured: From time 0 to 120 hours after a single dose
Secondary outcomes (3)
Maximum observed atorvastatin plasma concentration
Measured: From time 0 to 72 hours after a single dose
Maximum observed digoxin plasma concentration
Measured: From time 0 to 120 hours after a single dose
Number of treatment emergent AEs (TEAEs)
Measured: From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study start16 Sep 2014
- Primary completion7 Apr 2015
- Study completion7 Apr 2015
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 DiabetesStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243098
- Sponsor's protocol ID
- NN9535-3818
- Other IDs
- 2013-001288-22, U1111-1140-8551
- Status last verified
- Mar 2017
- First submitted
- 15 Sep 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6.
PubMed 28349387
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, One-sequence Cross Over, Single Centre Trial, Investigating the Influence of Semaglutide on the Pharmacokinetics of Single Doses of Atorvastatin and Digoxin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02243098
- Acronym / sponsor ID
- NN9535-3818
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2014 (actual)
- Primary completion
- 7 Apr 2015 (actual)
- Study completion
- 7 Apr 2015 (actual)
- First posted
- 17 Sep 2014 (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.
The trial is conducted in Europe. The aim of the trial is to investigate the influence of semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of single doses of atorvastatin and digoxin in healthy subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: semaglutide, Drug: digoxin, Drug: atorvastatin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Male and female, age between 18 and 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)
Key exclusion criteria (6 listed)
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control throughout the trial including the 5 weeks follow-up period. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine device), or sexual abstinence or vasectomised partner
- Any clinically significant disease history, in the opinion of the investigator, or systemic or organ disease including: cardiac, pulmonary, gastrointestinal, hepatic, neurologic, renal, genitourinary and endocrine, dermatologic or hematologic diseases
- Use of prescription or non-prescription systemic or topical medicinal products (including routine or non-routine vitamins or herbal supplements, but excluding paracetamol and contraceptives) within 3 weeks (or within 5 half-lives of the medicinal product, whichever is longest) prior to Visit 2 (first dose administration)
- History of drug/chemical substance abuse within 1 year from screening, or a positive result in the urine drug test
- History of alcohol abuse within 1 year from screening, or a positive result in the alcohol urine test, or consumption of more than 21 units (male)/14 units (female) of alcohol weekly (one unit of alcohol equals about 250 mL of beer or lager, one glass (120 mL) of wine, or 20 mL spirits)
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 |
|---|---|---|
| semaglutideAdministered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period. | Drug | Semaglutide |
| digoxinOral administration. Digoxin will be given as 2 single doses of 0.5 mg. | Drug | Semaglutide |
| atorvastatinOral administration. Atorvastatin will be given as 2 single doses of 40 mg. | Drug | Semaglutide |
Primary outcome
Area under the atorvastatin plasma concentration-time curve
Time frame: From time 0 to 72 hours after a single dose
Area under the digoxin plasma concentration-time curve
Time frame: From time 0 to 120 hours after a single dose
3 secondary outcomes
Maximum observed atorvastatin plasma concentration
Time frame: From time 0 to 72 hours after a single dose
Maximum observed digoxin plasma concentration
Time frame: From time 0 to 120 hours after a single dose
Number of treatment emergent AEs (TEAEs)
Time frame: From baseline (Visit 2, Day 1) to follow-up (Visit 12, 20 weeks after baseline)
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 4 Apr 2017.
- Results publication: PubMed 28349387Hausner H, Derving Karsbol J, Holst AG, Jacobsen JB, Wagner FD, Golor G, Anderson TW. Effect of Semaglutide on the Pharmacokinetics of Metformin, Warfarin, Atorvastatin and Digoxin in Healthy Subjects. Clin Pharmacokinet. 2017 Nov;56(11):1391-1401. doi: 10.1007/s40262-017-0532-6.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
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 semaglutide, digoxin and atorvastatin in people with Diabetes and 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 2 inclusion and 6 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 4 Apr 2017. 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. 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?
Area under the atorvastatin plasma concentration-time curve (time frame: From time 0 to 72 hours after a single dose). 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 NCT02243098, 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 4 Apr 2017.