Drug Interaction PotentiationPhase 1NCT03259542
Mifepristone Drug-Drug Interaction Study With CYP3A Inhibitor
A Phase 1 study testing Mifepristone 300 MG and Itraconazole 100 MG in people with Drug Interaction Potentiation and Healthy, run by Corcept Therapeutics at 1 site in United States.
Trial summary
This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Interaction Potentiation, Healthy
- What is being tested?
- Mifepristone 300 MG and Itraconazole 100 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2017to 11 Dec 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Be healthy
- Have a BMI of 18 to 32 kg/m2, inclusive and body weight more than 50 kg (110 pounds)
- Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
- Have suitable veins for multiple venipuncture/cannulation
Who cannot join
- Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
- In the 1 year before study drug administration, have a history of drug or alcohol abuse
- In the 6 calendar months before study drug administration, on average
- Have smoked more than 5 cigarettes/day
- Have consumed more than 21 units of alcohol/week (1 unit/drink = 5 ounces of wine, or 12 ounces of beer, or 1.5 ounces of hard liquor)
- In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
- In the 30 days before study drug administration, have participated in another clinical trial of a new chemical entity or a prescription medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
This is a Phase 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.
- Conditions
- Drug Interaction Potentiation, Healthy
- Being tested
- Mifepristone 300 MG, Itraconazole 100 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifepristone 300 MGDrug
mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days
Itraconazole 100 MGDrug
itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Mifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered. Receives: Drug: Mifepristone 300 MG; Drug: Itraconazole 100 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax of mifepristone at Day 42 compared to Day 28
Maximum (peak) plasma drug concentration (Cmax)
Measured: Day 42 compared to Day 28
AUC0-24 of mifepristone at Day 42 compared to Day 28
Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
Measured: Day 42 compared to Day 28
Secondary outcomes (4)
Cmax of mifepristone at Day 42 compared to Day 14
Measured: Day 42 compared to Day 14
AUC0-24 of mifepristone compared to Day 14
Measured: Day 42 compared to Day 14
T1/2 of mifepristone
Elimination half-life (T1/2)
Measured: Days 14 and 28
Ctrough of mifepristone
Trough plasma concentration (measured concentration at the end of a dosing interval at steady state [taken directly before next administration]) (Ctrough)
Measured: Days 1 through 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start9 Aug 2017
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Interaction PotentiationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corcept Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ada Lee, MD, Study director, Corcept Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259542
- Sponsor's protocol ID
- C1073-38
- Status last verified
- Oct 2017
- First submitted
- 7 Aug 2017
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-Drug Interaction Study in Healthy Subjects to Determine the Effects of a Strong Inhibitor (Itraconazole) of Cytochrome P450 3A on Exposure to Mifepristone and Its Metabolites
- ClinicalTrials.gov ID
- NCT03259542
- Acronym / sponsor ID
- C1073-38
- Conditions
- Drug Interaction Potentiation, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Corcept TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 9 Aug 2017 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 23 Aug 2017 (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 1, single-center, fixed-sequence, open label, drug-drug interaction study of the effect of multiple daily doses of oral itraconazole 200 mg, a strong inhibitor of CYP3A, given with mifepristone 900 mg QD, in healthy male subjects, where all drug administrations are given after a meal.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Mifepristone 300 MG, Drug: Itraconazole 100 MGMifepristone 300 MG alone or Mifepristone 300 MG with Itraconazole 100 MG will be administered. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be healthy
- Have a BMI of 18 to 32 kg/m2, inclusive and body weight more than 50 kg (110 pounds)
- Be judged to be in good health, based on the results of medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory findings
- Have suitable veins for multiple venipuncture/cannulation
Key exclusion criteria (8 listed)
- Have multiple drug allergies, or be allergic to any of the components of mifepristone or itraconazole
- Have a condition that could be aggravated by glucocorticoid blockade (eg, asthma, any chronic inflammatory condition)
- In the 1 year before study drug administration, have a history of drug or alcohol abuse
- In the 6 calendar months before study drug administration, on average
- In 2 months prior to study drug administration, have donated/lost blood or plasma in excess of 400 mL
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 |
|---|---|---|
| Mifepristone 300 MGmifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days | Drug | Arm 1 |
| Itraconazole 100 MGitraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing | Drug | Arm 1 |
Primary outcome
Cmax of mifepristone at Day 42 compared to Day 28
Time frame: Day 42 compared to Day 28
Maximum (peak) plasma drug concentration (Cmax)
AUC0-24 of mifepristone at Day 42 compared to Day 28
Time frame: Day 42 compared to Day 28
Area under the plasma concentration-time curve from zero to 24 hours (AUC0-24)
4 secondary outcomes
Cmax of mifepristone at Day 42 compared to Day 14
Time frame: Day 42 compared to Day 14
AUC0-24 of mifepristone compared to Day 14
Time frame: Day 42 compared to Day 14
T1/2 of mifepristone
Time frame: Days 14 and 28
Ctrough of mifepristone
Time frame: Days 1 through 28
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 22 Feb 2018.
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.
Ada Lee, MD study director
Corcept Therapeutics
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 Mifepristone 300 MG and Itraconazole 100 MG in people with Drug Interaction Potentiation and Healthy, run by Corcept Therapeutics 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 4 inclusion and 8 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 22 Feb 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 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?
Cmax of mifepristone at Day 42 compared to Day 28 (time frame: Day 42 compared to Day 28). 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?
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 22 Feb 2018.