AzTrials
AzTrials

HealthyPhase 1NCT01760642

Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity

A Phase 1 study testing Midazolam, Ketoconazole and Rifampicin in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Identification and evaluation of endogenous markers for the assessment of CYP3A activity in female subjects using metabolomics Read more about this study

Who is it for?
Ages 20 to 50 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Midazolam, Ketoconazole and Rifampicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteSouth Korea
Study dates
Dec 2012to Sep 2013
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 20 to 50 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Age: Between 20 to 50 years of age, inclusive
  • Weight: Between 45 to 95 kg, within 17 - 28 of Body Mass Index
  • Menstruation cycle between 21 to 35 without contraceptive
  • Subject who agree contraception during the study
  • Subject who are reliable and willing to make themselves available during the study period, are willing to follow the study protocol, and give their written informed consent voluntarily

Who cannot join

  • History of hypersensitive reaction to medication (midazolam, ketoconazole, rifampicin)
  • History of significant clinical illness needs medical caution, including cardiovascular, immunologic, hematologic, neuropsychiatric, respiratory, gastrointestinal, hepatic, or renal disease or other chronic disease history or evidence of drug abuse
  • A subject whose lab test results are as follows; Liver function test (AST, ALT, GGT, ALP, LDH, Total bilirubin) > 1.25 X upper limit of reference range
  • A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg
  • Presence or history of drug abuse or positive result in urine drug screening test
  • Blood donation during 2 months or apheresis during 1 month before the study
Show all 14Show fewer
  • Use any prescriptive medication, Korean traditional medication not considered acceptable by the clinical investigator during the last 14 days period before first dosing, or use any OTC medication not considered acceptable by the clinical investigator during the last 7 days period before first dosing (if used medication is considered acceptable by investigator, patients can be included)
  • Use of alcohol over 21 units/weeks
  • Smoker who smoke more than 10 cigarettes per day
  • Participation in clinical trials of any drug within 60 days prior to the participation of the study
  • Use of grapefruit juice within 1 week before first dose
  • Use of caffeine drink within 3 days before first dose
  • Subject pregnant or breast-feeding
  • Judged to be inappropriate for the study by the investigator

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National Universtiy Hospital

    Seoul, 110-744

Other trials in South Korea

About this study

Official title: Identification and Evaluation of Endogenous Markers for the Assessment of CYP3A Activity in Female Subjects Using Metabolomics

Identification and evaluation of endogenous markers for the assessment of CYP3A activity in female subjects using metabolomics

Read the detailed description

Eligibility for participation of this study will be determined from demographic information, medical history, physical examination, electrocardiogram(ECG) and clinical laboratory tests within 3 weeks before study drug administration. Subjects suitable for this study will be admitted to the Clinical Trials Center, Seoul National University Hospital on the day before dosing, and they will be overnight-fasted from 9 p.m. of Day -1. Urine collection is scheduled from 24 hours before midazolam administration to 24 hours after administration. Subjects will be dosed midazolam by intravenous around at 9 a.m. of Day 1. Subjects will perform scheduled procedures including clinical laboratory tests, electrocardiograms and pharmacokinetic samplings. Subjects will be discharged on Day 2 and visit the Clinical Trials Center for period 2, ketoconazole administration. After 3 days of ketoconazole administration, midazolam will be dosed with ketoconazole on Day 4 of period 2. Subjects will perform scheduled procedure and on period 3 rifampicin will be dosed for 9 days and on Day 10 of period 3 midazolam will be dosed with rifampicin. After subjects perform scheduled procedure, the study will be terminated 6-8 days after the end of period 3.

Conditions
Healthy
Being tested
Midazolam, Ketoconazole, Rifampicin
Keywords
metabolite profiles, pharmacokinetics, CYP3A, metabolomics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MidazolamDrug

    Also called Midazolam (Bukwang Pharm.Co., Ltd.)

    Midazolam 3 mg IV

  • KetoconazoleDrug

    Also called Kaszole (Skynewpharm Inc.)

    ketoconazole 400 mg PO

  • RifampicinDrug

    Also called Rifampin (Yuhan Corp.)

    Rifampicin 600 mg PO

Study groups in NCT01760642
Study groupRoleWhat they receive
MidazolamExperimentalperiod 1: midazolam 1 mg IV single dose administration. period 2: midazolam 1 mg IV single dose after ketoconazole 400 mg oral dosing for 3 days. period 3: midazolam 2.5 mg IV single dose after rifampicin 600 mg oral dosing for 10 days.
Receives: Drug: Midazolam; Drug: Ketoconazole; Drug: Rifampicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Metabolomic profile

    endogenous metabolite profiles such as steroid

    Measured: -24--12h, -12-0h of every midazolam dosing

Secondary outcomes (1)

  1. Pharmacokinetics

    Cmax, AUClast of midazolam

    Measured: 0h, 10m, 20m, 30m, 45m, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h of every midazolam dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jan 2013 (estimated)
  2. Study startDec 2012
  3. Primary completionSep 2013
  4. Study completionSep 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01760642
Sponsor's protocol ID
CYP_metabolomics
Status last verified
May 2014
First submitted
26 Dec 2012
Last updated
26 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Shin KH, Ahn LY, Choi MH, Moon JY, Lee J, Jang IJ, Yu KS, Cho JY. Urinary 6beta-Hydroxycortisol/Cortisol Ratio Most Highly Correlates With Midazolam Clearance Under Hepatic CYP3A Inhibition and Induction in Females: A Pharmacometabolomics Approach. AAPS J. 2016 Sep;18(5):1254-1261. doi: 10.1208/s12248-016-9941-y. Epub 2016 Jun 17.

    PubMed 27317471

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Midazolam, Ketoconazole and Rifampicin in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.

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 5 inclusion and 14 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 26 May 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 South Korea. 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?

Metabolomic profile (time frame: -24--12h, -12-0h of every midazolam dosing). 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 NCT01760642, 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 26 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in