Healthy SubjectsPhase 1NCT03880825
Drug Interaction Study of Levoketoconazole and Metformin
A Phase 1 study testing Metformin 500 mg Oral Tablet and Levoketoconazole 150 - 600 mg (BID) in people with Healthy Subjects, run by Cortendo AB at 1 site in United States.
Trial summary
This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Metformin 500 mg Oral Tablet and Levoketoconazole 150 - 600 mg (BID)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2019to 3 May 2019
- 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
- 18-55 years of age, inclusive, at time of consent.
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
- In good general physical health as determined by absence of clinically significant medical history, physical examination findings, vital signs, clinical laboratory evaluations and ECG measurements.
- Has not consumed and agrees to abstain from taking any prescription drugs, dietary supplements including vitamins and herbal preparations, or non-prescription drugs (except as authorized by the Investigator AND Medical Monitor) for 14 days prior to initial CRU admission on Day -1 and through Follow-Up.
- Has not consumed alcohol-containing beverages for 3 days prior to initial CRU admission on Day -1 and agrees not to consume alcohol for the duration of the study through Follow-Up.
- Is a nonsmoker (for at least 3 months) with negative urinary cotinine test at Screening and agrees to abstain from tobacco- and nicotine containing products for the duration of the study.
Who cannot join
- Evidence of any out-of-normal-range laboratory value at Screening that has not been reviewed, approved, and documented as Not Clinically Significant by the Investigator (except for LFTs, which must be within the normal range).
- Concurrent medical illness that would interfere with the conduct of the study in the opinion of the Investigator.
- History or presence of clinically significant cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease as judged by the Investigator.
- Clinically significant ECG abnormality or confirmed QTcF interval > 450 msec at Screening or unconfirmed QTcF interval > 450 msec at CRU admission.
- Family history (parents, siblings, and offspring) of QT interval sudden cardiac death.
- Positive urine drug screen for drugs-of-abuse, including cocaine, 3,4 methylenedioxy-methamphetamine (MDMA), tetrahydrocannabinol, opioids, benzodiazepines, amphetamines, and barbiturates, and/or positive urine screen for alcohol at Screening and CRU admission.
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- Positive urinary cotinine test at Screening.
- Treatment with an investigational drug within the longer of 30 days or five half-lives of the investigational drug preceding the first dose of study drug.
- Positive for Human Immunodeficiency Virus (HIV), hepatitis B, and/or hepatitis C on Screening assessments.
- Acute illness within 7 days of the first CRU admission on Day -1.
- Donated plasma within 7 days of Screening.
- Donated 1 or more pints of blood (or equivalent blood loss) within 30 days prior to Screening.
- History of caffeine consumption exceeding 8 cups of coffee/day (1 cup = 8 fluid ounces) within 14 days prior to first dose, or consumption of any caffeine- or chocolate-containing products for 3 days prior to CRU admission each week. Caffeine containing foods and/or beverages (e.g., tea and cola) should be considered equivalent to coffee.
- History of regular alcohol consumption exceeding 14 drinks/week (1 drink = 5 ounces of wine, 12 ounces of beer, or 1.5 ounces of hard liquor) within 180 days of Screening.
- Female subject who is pregnant or lactating.
- Male with hemoglobin less than 12.0 g/dL; Female with hemoglobin less than 11.0 g/dL.
- Had difficulties swallowing whole tablets.
- Body habitus prevents repeated venipuncture.
- History of hypersensitivity or allergy to metformin.
- History of hypoglycemia.
- Participated in the COR-2017-02 levoketoconazole food effect study.
- History of drug-induced liver injury from any drug.
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
About this study
Official title: A Phase I Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Levoketoconazole on the Single-Dose Pharmacokinetics of Metformin in Healthy Subjects
This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.
Read the detailed description
This study will enroll healthy male and female subjects to evaluate the effect of levoketoconazole on the PK of a single 500 mg dose of metformin. There will be 3 sequential treatment periods, and all subjects will receive metformin only in Period 1, escalating doses of levoketoconazole in Period 2, and concurrent administration of metformin and levoketoconazole in Period 3.
- Conditions
- Healthy Subjects
- Being tested
- Metformin 500 mg Oral Tablet, Levoketoconazole 150 - 600 mg (BID)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin 500 mg Oral TabletDrug
single dose
Levoketoconazole 150 - 600 mg (BID)Drug
Also called COR-003
escalating dose from 150 mg to 600 mg (BID)
| Study group | Role | What they receive |
|---|---|---|
| Metformin Only | Other | Not described Receives: Drug: Metformin 500 mg Oral Tablet |
| Levoketoconazole Only | Other | Not described Receives: Drug: Levoketoconazole 150 - 600 mg (BID) |
| Levoketoconazole + Metformin | Other | Not described Receives: Drug: Metformin 500 mg Oral Tablet; Drug: Levoketoconazole 150 - 600 mg (BID) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of metformin
Maximum observed plasma concentration (Cmax) of metformin with and without concomitant administration of levoketoconazole.
Measured: 48 hours
Time to maximum concentration (Tmax) of metformin
Time to maximum concentration (Tmax) of metformin with and without concomitant administration of levoketoconazole.
Measured: 48 hours
Area under the plasma concentration-time curve (AUC) of metformin
Area under the plasma concentration-time curve (AUC) from time 0 to time of last measurable plasma concentration (AUClast) and from time 0 extrapolated to infinity (AUCinf) of metformin with and without concomitant administration of levoketoconazole.
Measured: 48 hours
Secondary outcomes (2)
Renal clearance (CLr) of metformin
Renal clearance (CLr) of metformin with and without concomitant administration of levoketoconazole.
Measured: 24 hours
Incidence of Adverse Events
Incidence of Treatment-Emergent AEs (TEAEs), AESIs, and Serious Adverse Events (SAEs).
Incidence of Treatment-Emergent AEs (TEAEs), AESIs, and Serious Adverse Events (SAEs).
Measured: 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start28 Mar 2019
- Primary completion3 May 2019
- Study completion3 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortendo AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Schoenfeld, MD, Study director, Cortendo AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880825
- Sponsor's protocol ID
- COR-2017-03
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-Label, Fixed-Sequence Pharmacokinetic Drug Interaction Study to Evaluate the Effect of Levoketoconazole on the Single-Dose Pharmacokinetics of Metformin in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03880825
- Acronym / sponsor ID
- COR-2017-03
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cortendo ABIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2019 (actual)
- Primary completion
- 3 May 2019 (actual)
- Study completion
- 3 May 2019 (actual)
- First posted
- 19 Mar 2019 (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.
This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the effect of levoketoconazole on the single-dose PK of metformin in health subjects.
Detailed description
This study will enroll healthy male and female subjects to evaluate the effect of levoketoconazole on the PK of a single 500 mg dose of metformin. There will be 3 sequential treatment periods, and all subjects will receive metformin only in Period 1, escalating doses of levoketoconazole in Period 2, and concurrent administration of metformin and levoketoconazole in Period 3.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Metformin Only | Other | Drug: Metformin 500 mg Oral Tablet |
| Levoketoconazole Only | Other | Drug: Levoketoconazole 150 - 600 mg (BID) |
| Levoketoconazole + Metformin | Other | Drug: Metformin 500 mg Oral Tablet, Drug: Levoketoconazole 150 - 600 mg (BID) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 18-55 years of age, inclusive, at time of consent.
- Body mass index (BMI) between 18 and 32 kg/m2, inclusive.
- In good general physical health as determined by absence of clinically significant medical history, physical examination findings, vital signs, clinical laboratory evaluations and ECG measurements.
- Has not consumed and agrees to abstain from taking any prescription drugs, dietary supplements including vitamins and herbal preparations, or non-prescription drugs (except as authorized by the Investigator AND Medical Monitor) for 14 days prior to initial CRU admission on Day -1 and through Follow-Up.
- Has not consumed alcohol-containing beverages for 3 days prior to initial CRU admission on Day -1 and agrees not to consume alcohol for the duration of the study through Follow-Up.
Key exclusion criteria (22 listed)
- Evidence of any out-of-normal-range laboratory value at Screening that has not been reviewed, approved, and documented as Not Clinically Significant by the Investigator (except for LFTs, which must be within the normal range).
- Concurrent medical illness that would interfere with the conduct of the study in the opinion of the Investigator.
- History or presence of clinically significant cardiovascular, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic, psychiatric, renal, hepatic, chronic respiratory, or gastrointestinal disease as judged by the Investigator.
- Clinically significant ECG abnormality or confirmed QTcF interval > 450 msec at Screening or unconfirmed QTcF interval > 450 msec at CRU admission.
- Family history (parents, siblings, and offspring) of QT interval sudden cardiac death.
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 |
|---|---|---|
| Metformin 500 mg Oral Tabletsingle dose | Drug | Levoketoconazole + Metformin, Metformin Only |
| Levoketoconazole 150 - 600 mg (BID)Also: COR-003escalating dose from 150 mg to 600 mg (BID) | Drug | Levoketoconazole + Metformin, Levoketoconazole Only |
Primary outcome
Maximum observed plasma concentration (Cmax) of metformin
Time frame: 48 hours
Maximum observed plasma concentration (Cmax) of metformin with and without concomitant administration of levoketoconazole.
Time to maximum concentration (Tmax) of metformin
Time frame: 48 hours
Time to maximum concentration (Tmax) of metformin with and without concomitant administration of levoketoconazole.
Area under the plasma concentration-time curve (AUC) of metformin
Time frame: 48 hours
Area under the plasma concentration-time curve (AUC) from time 0 to time of last measurable plasma concentration (AUClast) and from time 0 extrapolated to infinity (AUCinf) of metformin with and without concomitant administration of levoketoconazole.
2 secondary outcomes
Renal clearance (CLr) of metformin
Time frame: 24 hours
Incidence of Adverse Events
Time frame: 35 days
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 30 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Steven Schoenfeld, MD study director
Cortendo AB
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 Metformin 500 mg Oral Tablet and Levoketoconazole 150 - 600 mg (BID) in people with Healthy Subjects, run by Cortendo AB at 1 site 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 6 inclusion and 22 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 30 Aug 2019. 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 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?
Maximum observed plasma concentration (Cmax) of metformin (time frame: 48 hours). The study lists 3 primary outcomes in all. 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 30 Aug 2019.