HealthyPhase 1NCT02233244
Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam
A Phase 1 study testing CTX-4430 and Midazolam in people with Healthy, run by Celtaxsys, Inc. at 1 site in United Kingdom.
Trial summary
This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A activity in healthy subjects. The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood levels will not change after treatment with CTX-4430. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- CTX-4430 and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2014to Oct 2014
- 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
- Healthy adult male or female, 18-55 years of age, inclusive at screening
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI
- For a female of childbearing potential: either be sexually inactive (true abstinence in line with the preferred and usual lifestyle of the subject) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
- non-hormone releasing intrauterine device in place for at least 3 months prior to the first dose with a physical (e.g. condom or diaphragm or other) and a chemical barrier (e.g. spermicide) from the time of screening through 14 days following the last dose
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- double physical barrier (e.g. condom and diaphragm or other) and a chemical barrier (e.g. spermicide) from the time of screening through 14 days following the last dose
- surgical sterilization of the partner (vasectomy for 180 days minimum) with a physical (e.g. condom or diaphragm or other) and a chemical barrier (e.g. spermicide) from the time of screening through 14 days following the last dose.
- or have an exclusive non-heterosexual lifestyle
- In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for at least 14 days following the last dose
- Female of non childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to the first dose:
- hysteroscopy sterilization (with a copy of the confirmation test) and be using a physical (e.g. condom or diaphragm or other) and a chemical barrier (e.g. spermicide) a barrier method (e.g., condom or diaphragm) with spermicide throughout the study
- bilateral tubal ligation or bilateral salpingectomy and be using a physical (e.g. condom or diaphragm or other) and a chemical barrier (e.g. spermicide) a barrier method (e.g., condom or diaphragm) with spermicide throughout the study
- hysterectomy
- bilateral oophorectomy or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and FSH serum levels consistent with postmenopausal status
- A non vasectomized, male subject must agree to use a condom with spermicide or abstain from sexual intercourse during the study until 90 days beyond the last dose of study drug. (No restrictions are required for a vasectomized male provided his vasectomy has been performed 4 months or more prior to study start. A male who has been vasectomized less than 4 months prior to study start must follow the same restrictions as a non vasectomized male)
- If male, must agree not to donate sperm from the first dose until 90 days after dosing
- A subject who claims to be sexually inactive needs to remain inactive for the whole study duration
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol
Who cannot join
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of chronic alcohol or drug abuse the past 2 years prior to screening
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds (e.g., any other benzodiazepine for midazolam since cross sensitivity with other benzodiazepines is possible) or any component of the midazolam solution formulation
- Subject is currently taking or has a history of pronounced sedation upon taking benzodiazepines or other sedative/soporific drugs
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- Female subjects who are pregnant or lactating
- Positive urine drug results at screening or check-in or positive alcohol results at check in
- Drink alcohol in excess of 21 glasses/units per week for males or 14 glasses/units per week for females, with one unit = 150 mL of wine or 360 mL of beer or 45 mL of 45% alcohol
- Positive urine cotinine at screening
- Positive results at screening for HIV, HBsAg or HCV
- Seated blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg at screening
- Seated heart rate is lower than 40 bpm or higher than 99 bpm at screening
- QTcF interval is >430 msec (males) or >450 msec (females) or deemed clinically abnormal by the PI
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dose of study drug and throughout the study. Hormonal contraceptives and hormone replacement therapy will not be allowed. Paracetamol (up to 2 g per 24 hour period) may be permitted during the study.
- Any drugs, foods, or herbal preparations known to be significant inducers of CYP enzymes and/or Pgp, including St. John's Wort, for 28 days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/PD interaction with study drug.
- Have been on a diet incompatible with the on study diet, in the opinion of the PI, within the 28 days prior to the first dose of study drug(s), and throughout the study
- Donation of blood or plasma within 90 days prior to the first dose of study drug
- Donation of bone marrow within the last 6 months prior to the first dose of study drug
- Participation in another clinical trial within 90 days prior to the first dose of study drug. The 90 day window will be derived from the date of the last study scheduled blood collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Two-Period, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam in Healthy Adult Subjects
This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A activity in healthy subjects.
The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood levels will not change after treatment with CTX-4430.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTX-4430Drug
MidazolamDrug
| Study group | Role | What they receive |
|---|---|---|
| CTX-4430 and midazolam | Other | Midazolam 2 mg solution once, CTX-4430 100 mg tablet once per day for 7 days, Midazolam 2 mg solution once Receives: Drug: CTX-4430; Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the change in maximum plasma concentration (Cmax) and area under the curve (AUC) for both midazolam and 1-OH-midazolam after 7 days of treatment with CTX-4430
Measured: 10 days
Secondary outcomes (2)
To evaluate the safety and tolerability of the administration of single oral doses of midazolam, both in the absence and presence of multiple dose CTX-4430.
Safety and tolerability assessments include Adverse Event monitoring, Physical Examinations, Vital Sign assessments (heart rate, blood pressure, respiratory rate and temperature), Pulse Oximetry assessments, ECG assessments and Pregnancy testing in female subjects.
Measured: 10 days
To evaluate the safety and tolerability of multiple oral doses of CTX-4430.
Safety and tolerability assessments include Adverse Event monitoring, Physical Examinations, Vital Sign assessments (heart rate, blood pressure, respiratory rate and temperature), Pulse Oximetry assessments, ECG assessments and Pregnancy testing in female subjects.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celtaxsys, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johnston Stewart, MB, BSc, Principal investigator, Celerion Belfast, Northern Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233244
- Sponsor's protocol ID
- CTX-4430-DI-001
- Status last verified
- Oct 2014
- First submitted
- 22 Jul 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Period, Fixed-Sequence, Drug-Drug Interaction Study to Evaluate the Pharmacokinetics and Safety of CTX 4430 and Midazolam in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT02233244
- Acronym / sponsor ID
- CTX-4430-DI-001
- Conditions
- Healthy
- Keywords
- Drug Interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Celtaxsys, Inc.University, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 8 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.
This drug-drug interaction study will assess the potential of CTX-4430 to induce CYP3A activity in healthy subjects.
The study hypothesis is that midazolam (a sensitive, widely used CYP3A4 substrate) blood levels will not change after treatment with CTX-4430.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CTX-4430 and midazolam | Other | Drug: CTX-4430, Drug: MidazolamMidazolam 2 mg solution once, CTX-4430 100 mg tablet once per day for 7 days, Midazolam 2 mg solution once |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Healthy adult male or female, 18-55 years of age, inclusive at screening
- Continuous non-smoker who has not used nicotine-containing products for at least 3 months prior to the first dose
- Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI
- For a female of childbearing potential: either be sexually inactive (true abstinence in line with the preferred and usual lifestyle of the subject) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
Key exclusion criteria (21 listed)
- Subject is mentally or legally incapacitated or has significant emotional problems at the time of screening visit or expected during the conduct of the study
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI
- History of any illness that, in the opinion of the PI, might confound the results of the study or poses an additional risk to the subject by their participation in the study
- History or presence of chronic alcohol or drug abuse the past 2 years prior to screening
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug(s) or related compounds (e.g., any other benzodiazepine for midazolam since cross sensitivity with other benzodiazepines is possible) or any component of the midazolam solution formulation
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 |
|---|---|---|
| CTX-4430 | Drug | CTX-4430 and midazolam |
| Midazolam | Drug | CTX-4430 and midazolam |
Primary outcome
To evaluate the change in maximum plasma concentration (Cmax) and area under the curve (AUC) for both midazolam and 1-OH-midazolam after 7 days of treatment with CTX-4430
Time frame: 10 days
2 secondary outcomes
To evaluate the safety and tolerability of the administration of single oral doses of midazolam, both in the absence and presence of multiple dose CTX-4430.
Time frame: 10 days
To evaluate the safety and tolerability of multiple oral doses of CTX-4430.
Time frame: 10 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 10 Oct 2014.
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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.
Johnston Stewart, MB, BSc principal investigator
Celerion Belfast, Northern Ireland
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 CTX-4430 and Midazolam in people with Healthy, run by Celtaxsys, Inc. at 1 site in United Kingdom.
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 19 inclusion and 21 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 10 Oct 2014. 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 Kingdom. 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?
To evaluate the change in maximum plasma concentration (Cmax) and area under the curve (AUC) for both midazolam and 1-OH-midazolam after 7 days of treatment with CTX-4430 (time frame: 10 days). 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 10 Oct 2014.