PharmacokineticsPhase 1NCT02175407
A Study to Assess the Interaction Between ASP1707 and Itraconazole in Healthy Female Subjects
A Phase 1 study testing ASP1707 and itraconazole in people with Pharmacokinetics and DDI (Drug-Drug Interaction), run by Astellas Pharma Europe B.V. at 1 site in Germany.
Trial summary
The purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in combination with itraconazole. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, DDI (Drug-Drug Interaction), Healthy Subjects
- What is being tested?
- ASP1707 and itraconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to Jun 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subject must be either of non child bearing potential, post-menopausal prior to screening, or documented surgically sterile. Or, if of childbearing potential, must agree not to try to become pregnant during the study and for 28 days after the final study drug administration, must have a negative urine pregnancy test at Day -1 and, if heterosexually active, agree to consistently use two forms of highly effective form of birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
- Female subject must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
Who cannot join
- Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
- Subject uses grapefruit (more than 3x 200 mL) or marmalade (more than three times) in the week prior to admission to the Clinical Unit until ESV, as reported by the subject.
- Subject is a vulnerable subject (e.g., subject kept in detention).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, One Sequence, Cross-over Pharmacokinetic Study to Assess the Interaction Between ASP1707 and Itraconazole, a CYP3A and P-gp Inhibitor in Healthy Female Subjects
The purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in combination with itraconazole.
Read the detailed description
Subjects will be confined in the clinical unit for up to 15 days.
- Being tested
- ASP1707, itraconazole
- Keywords
- Healthy subjects, ASP1707, Itraconazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASP1707Drug
oral
itraconazoleDrug
oral
| Study group | Role | What they receive |
|---|---|---|
| ASP1707 alone | Experimental | Not described Receives: Drug: ASP1707 |
| ASP1707 + itraconazole | Experimental | Not described Receives: Drug: ASP1707; Drug: itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: AUCinf
Area under the plasma concentration - time curve from time zero to infinity (AUCinf)
Measured: Day 1-15
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: AUCinf
Measured: Day 1-15
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: Cmax
Maximum concentration (Cmax)
Measured: Day 1-15
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: Cmax
Measured: Day 1-15
Secondary outcomes (3)
Composite of pharmacokinetics of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 concentration with itraconazole: AUClast, tmax, t1/2, AUCinf (%extrap), tlag, MRT, λz, CL/F, Vz/F, TER and MPR
Area under the plasma concentration - time curve from time zero to time of last measurable concentration (AUClast), Time to attain Cmax (tmax), apparent terminal elimination half life (t1/2), area under the concentration-time curve from the time of dosing extrapolated to time infinity (AUCinf [%extrap]), absorption lag time (tlag), Mean Residence Time (MRT), terminal elimination rate constant (λz), apparent total systemic clearance (CL/F) (ASP1707 (=R-enantiomer) only), apparent volume of distribution during terminal elimination phase (Vz/F) (ASP1707 only), total exposure ratio (TER) and metabolite-parent ratio (MPR) (AS1948006 only)
Measured: Day 1-15
Composite of pharmacokinetics of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 concentration without itraconazole: AUClast, tmax, t1/2, AUCinf (%extrap), tlag, MRT, λz, CL/F, Vz/F, TER and MPR
CL/F (ASP1707 (=R-enantiomer) only), Vz/F (ASP1707 only), MPR (AS1948006 only)
Measured: Day 1-15
Composite of pharmacokinetics of itraconazole and hydroxy itraconazole concentrations with ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006: AUCtau, tmax, Cmax, MPR (hydroxy itraconazole only), Ctrough
Area under the plasma concentration - time curve between consecutive dosing (AUCtau), plasma concentration at the end of a dosing interval at steady state (Ctrough)
Measured: Days 4-15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Europe B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Medical Lead, Study director, Astellas Pharma Global Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02175407
- Sponsor's protocol ID
- 1707-CL-0030
- Other IDs
- 2013-005370-21
- Status last verified
- Jul 2014
- First submitted
- 24 Jun 2014
- Last updated
- 3 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, One Sequence, Cross-over Pharmacokinetic Study to Assess the Interaction Between ASP1707 and Itraconazole, a CYP3A and P-gp Inhibitor in Healthy Female Subjects
- ClinicalTrials.gov ID
- NCT02175407
- Acronym / sponsor ID
- 1707-CL-0030
- Keywords
- Healthy subjects, ASP1707, Itraconazole
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Astellas Pharma Europe B.V.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Jun 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.
The purpose of this study to explore the effect of multiple oral doses of itraconazole on the pharmacokinetics of a single oral dose of ASP1707 in healthy female subjects. This study will also evaluate the safety and tolerability of a single oral dose of ASP1707 alone and in combination with itraconazole.
Detailed description
Subjects will be confined in the clinical unit for up to 15 days.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASP1707 alone | Experimental | Drug: ASP1707 |
| ASP1707 + itraconazole | Experimental | Drug: ASP1707, Drug: itraconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female subject must be either of non child bearing potential, post-menopausal prior to screening, or documented surgically sterile. Or, if of childbearing potential, must agree not to try to become pregnant during the study and for 28 days after the final study drug administration, must have a negative urine pregnancy test at Day -1 and, if heterosexually active, agree to consistently use two forms of highly effective form of birth control starting at screening and throughout the study period and for 28 days after the final study drug administration.
- Female subject must not be breastfeeding at screening or during the study period, and for 28 days after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period, and for 28 days after the final study drug administration.
Key exclusion criteria (3 listed)
- Female subject who has been pregnant within 6 months prior to screening assessment or breast feeding within 3 months prior to screening.
- Subject uses grapefruit (more than 3x 200 mL) or marmalade (more than three times) in the week prior to admission to the Clinical Unit until ESV, as reported by the subject.
- Subject is a vulnerable subject (e.g., subject kept in detention).
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 |
|---|---|---|
| ASP1707oral | Drug | ASP1707 + itraconazole, ASP1707 alone |
| itraconazoleoral | Drug | ASP1707 + itraconazole |
Primary outcome
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: AUCinf
Time frame: Day 1-15
Area under the plasma concentration - time curve from time zero to infinity (AUCinf)
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: AUCinf
Time frame: Day 1-15
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: Cmax
Time frame: Day 1-15
Maximum concentration (Cmax)
Pharmacokinetic parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 without itraconazole: Cmax
Time frame: Day 1-15
3 secondary outcomes
Composite of pharmacokinetics of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 concentration with itraconazole: AUClast, tmax, t1/2, AUCinf (%extrap), tlag, MRT, λz, CL/F, Vz/F, TER and MPR
Time frame: Day 1-15
Composite of pharmacokinetics of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 concentration without itraconazole: AUClast, tmax, t1/2, AUCinf (%extrap), tlag, MRT, λz, CL/F, Vz/F, TER and MPR
Time frame: Day 1-15
Composite of pharmacokinetics of itraconazole and hydroxy itraconazole concentrations with ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006: AUCtau, tmax, Cmax, MPR (hydroxy itraconazole only), Ctrough
Time frame: Days 4-15
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 3 Jul 2014.
Related trials for Pharmacokinetics
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
RecruitingPhase 1
A Clinical Study of Letermovir (MK-8228) in Children and Adolescents Who Receive a Kidney Transplant (KT) (MK-8228-077)
Cytomegalovirus Prophylaxis
Not yet recruitingPhase 1
A Study of Single Ascending Doses of NI112 in Adults With Amyotrophic Lateral Sclerosis (ALS)
Amyotrophic Lateral Sclerosis (ALS)
Active, not recruitingPhase 1
Safety and Pharmacokinetics of LPX-TI641 in Rheumatoid Arthritis and Psoriatic Arthritis
Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA)
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.
Global Medical Lead study director
Astellas Pharma Global Development, Inc.
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 ASP1707 and itraconazole in people with Pharmacokinetics and DDI (Drug-Drug Interaction), run by Astellas Pharma Europe B.V. at 1 site in Germany.
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 3 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 3 Jul 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 Germany. 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 parameter of ASP1707 (=R-enantiomer), AS1948006 and the sum of ASP1707 and AS1948006 with itraconazole: AUCinf (time frame: Day 1-15). The study lists 4 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 3 Jul 2014.