Pharmacokinetics of IsavuconazolePhase 1NCT01597986

Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

A Phase 1 study testing isavuconazole and Oral Contraceptive (ethinyl estradiol / norethindrone) in people with Pharmacokinetics of Isavuconazole and Pharmacokinetics of Ethinyl Estradiol and Norethindrone, run by Astellas Pharma Global Development, Inc. at 1 site in United States.

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

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women. Read more about this study

Who is it for?: Ages 50 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone, Healthy Volunteers
What is being tested?: isavuconazole and Oral Contraceptive (ethinyl estradiol / norethindrone)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Apr 2012to Jun 2012
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 50 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubim must not be above upper limit of normal range
The subject must be postmenopausal, defined as at least 2 years since the last regular menstrual cycle and have follicle stimulating hormone (FSH) > 30 IU/L

Who cannot join

The subject has had treatment with hormone replacement therapy within 3 months prior to Day -1
The subject has a history of adverse events with taking oral contraceptives or hormone replacement therapy
The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions
The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Pharmacology of Miami
Miami, Florida, 33014

Other trials in United States

About this study

Official title: A Phase 1, Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.

Conditions: Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone, Healthy Volunteers
Being tested: isavuconazole, Oral Contraceptive (ethinyl estradiol / norethindrone)
Keywords: isavuconazole, ethinyl estradiol, norethindrone, contraceptive, Healthy Volunteers, BAL8557, BAL4815

What participants receive

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

isavuconazoleDrug
Also called BAL8557, BAL4815
oral
Oral Contraceptive (ethinyl estradiol / norethindrone)Drug
Also called Ortho-Novum
contraceptive pill consisting of ethinyl estradiol and norethindrone

Study groups in NCT01597986
Study group	Role	What they receive
Isavuconazole and oral contraceptive	Experimental	Arm description(as needed): Subjects receive single dose of oral contraceptive consisting of ethinyl estradiol and norethindrone on Days 1 and 13 and oral doses of isavuconazole every 8 hours on Days 9 and 10 followed by a once a day dose in the mornings on Days 11 through 16. Receives: Drug: isavuconazole; Drug: Oral Contraceptive (ethinyl estradiol / norethindrone)

What is being measured

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

Pharmacokinetic (PK) variables for ethinyl estradiol and norethindrone (in plasma): AUCinf , AUClast, and Cmax
AUC from time 0 extrapolated to infinity (AUCinf), Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)
Measured: For Days 1 and 13: predose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day

Secondary outcomes (4)

PK variable for ethinyl estradiol and norethindrone (in plasma): tmax , t1/2 , Vz /F, and CL/F
Time to attain Cmax (tmax) , apparent terminal elimination half-life (t1/2 ), apparent volume of distribution (Vz /F), apparent body clearance after oral dosing (CL/F)
Measured: For Days 1 and 13: pre-dose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day
PK variable for isavuconazole (in plasma): Ctrough
trough concentration (Ctrough)
Measured: For Day 11: predose; for Days 12 and 13: predose and 12 times post dose; for Day 14 and 15: predose; and for Day 16: predose and 24 hours post dose
PK variable for isavuconazole (in plasma): AUCtau, Cmax, and tmax
Area under the concentration-time curve during the time interval between consecutive dosing (AUCtau)
Measured: For Days 12 and 13: predose and 12 times post dose
Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs)
Measured: Day 1 through Day 24 ± 2 days

Timeline

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

Apr 2012Jun 2012

First posted15 May 2012 (estimated)
Study startApr 2012
Primary completionJun 2012
Study completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pharmacokinetics of IsavuconazoleStudies of the same condition, open and under way.
More trials run by Astellas Pharma Global Development, Inc.The 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
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01597986
Sponsor's protocol ID: 9766-CL-0031
Status last verified: Jul 2012
First submitted: 7 May 2012
Last updated: 16 Jul 2012
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open Label Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of a Single Dose Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone
ClinicalTrials.gov ID: NCT01597986
Acronym / sponsor ID: 9766-CL-0031
Conditions: Pharmacokinetics of Isavuconazole, Pharmacokinetics of Ethinyl Estradiol and Norethindrone, Healthy Volunteers
Keywords: isavuconazole, ethinyl estradiol, norethindrone, contraceptive, Healthy Volunteers, BAL8557, BAL4815
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Astellas Pharma Global Development, Inc.Industry (pharma, biotech, devices)
Collaborators: Basilea Pharmaceutica International Ltd
Study start: Apr 2012
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 15 May 2012 (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 purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.

Study design

Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Isavuconazole and oral contraceptive	Experimental	Drug: isavuconazole, Drug: Oral Contraceptive (ethinyl estradiol / norethindrone)Arm description(as needed): Subjects receive single dose of oral contraceptive consisting of ethinyl estradiol and norethindrone on Days 1 and 13 and oral doses of isavuconazole every 8 hours on Days 9 and 10 followed by a once a day dose in the mornings on Days 11 through 16.

Who may qualify

Ages: 50 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubim must not be above upper limit of normal range
The subject must be postmenopausal, defined as at least 2 years since the last regular menstrual cycle and have follicle stimulating hormone (FSH) > 30 IU/L

Key exclusion criteria (8 listed)

The subject has had treatment with hormone replacement therapy within 3 months prior to Day -1
The subject has a history of adverse events with taking oral contraceptives or hormone replacement therapy
The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions

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
isavuconazoleAlso: BAL8557, BAL4815oral	Drug	Isavuconazole and oral contraceptive
Oral Contraceptive (ethinyl estradiol / norethindrone)Also: Ortho-Novumcontraceptive pill consisting of ethinyl estradiol and norethindrone	Drug	Isavuconazole and oral contraceptive

Primary outcome

Pharmacokinetic (PK) variables for ethinyl estradiol and norethindrone (in plasma): AUCinf , AUClast, and Cmax
Time frame: For Days 1 and 13: predose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day
AUC from time 0 extrapolated to infinity (AUCinf), Area under the curve (AUC) from time of dosing to last quantifiable concentration (AUClast ), and maximum concentration (Cmax)

4 secondary outcomes

PK variable for ethinyl estradiol and norethindrone (in plasma): tmax , t1/2 , Vz /F, and CL/F
Time frame: For Days 1 and 13: pre-dose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day
PK variable for isavuconazole (in plasma): Ctrough
Time frame: For Day 11: predose; for Days 12 and 13: predose and 12 times post dose; for Day 14 and 15: predose; and for Day 16: predose and 24 hours post dose
PK variable for isavuconazole (in plasma): AUCtau, Cmax, and tmax
Time frame: For Days 12 and 13: predose and 12 times post dose
Safety assessed by recording adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs)
Time frame: Day 1 through Day 24 ± 2 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 16 Jul 2012.

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.

Medical Director study director

Astellas Pharma Global Development

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 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 16 Jul 2012. 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?

Pharmacokinetic (PK) variables for ethinyl estradiol and norethindrone (in plasma): AUCinf , AUClast, and Cmax (time frame: For Days 1 and 13: predose and 12 times post dose; for Days 2, 3, 4, 5, 14, 15, 16, and 17: one time each day). 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 NCT01597986.

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 16 Jul 2012.