Prostate CancerPhase 1NCT02093390
A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects
A Phase 1 study testing TAK-385, Fluconazole and Atorvastatin in people with Prostate Cancer and Endometriosis, run by Millennium Pharmaceuticals, Inc..
Trial summary
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Endometriosis
- What is being tested?
- TAK-385, Fluconazole and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Apr 2014
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Each subject must meet all the following inclusion criteria to be enrolled in the study:
- Age 18 to 55 years, inclusive, at the time of consent.
- Healthy adult male or female in good health, as determined by a physician evaluation
- Weight ≥ 45 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
- Nonsmoker and does not use tobacco-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).
- Exclusion Criteria Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.
Show all 16Show fewer
- The subject has a history of drug abuse (defined as any illicit drug use) within 1 year before screening or is unwilling to abstain from drugs throughout the study.
- The subject is unwilling to agree to abstain from caffeine and alcohol-containing products from 72 hours before check-in (Day -1) to completion of the final assessment.
- The subject has taken any prescription medicine or herbal preparations (eg, St John's wort) or received any immunizations within 30 days before check-in (Day -1).
- The subject has taken any over the counter (OTC) medications or vitamin supplements within 14 days before check-in (Day -1). The subject is unwilling to agree to abstain from consumption of grapefruit or grapefruit-containing products from 72 hours before check-in (Day -1) to completion of the final assessment.
- The subject has current or recent (within 6 months) history of gastrointestinal disease that would be expected to influence the absorption of drugs.
- The subject has a positive test result for hepatitis B surface antigen, hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody or antigen, or serological reactions for syphilis at screening.
- The subject has a clinically significant ECG abnormality at screening or check-in (Day -1) or a QTc interval (by Fridericia's correction) of 450 msec or greater, or the subject has a history of cardiac disease.
- The subject has abnormal laboratory values suggesting a clinically significant disease at screening or check-in (Day -1) .
- Female subjects who are lactating and breastfeeding or pregnant before the first dose of study drug.
- Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Who cannot join
None listed.
About this study
Official title: A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Fluconazole and Atorvastatin on the Pharmacokinetics of a Single Oral Dose of TAK-385 in Healthy Subjects
This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
Read the detailed description
The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if the way it is processed the body changes when it administered with other medications (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385.
The study enrolled 40 patients. Participants were assigned to one of the two treatment groups:
- TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14
- TAK-385 40 mg and atorvastatin 80 mg on Days 6-14
Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14.
This single-center trial was conducted in the United States. The overall time to participate in this study was 4 weeks. Participants made multiple visits to the clinic, including one 16-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.
- Conditions
- Prostate Cancer, Endometriosis
- Being tested
- TAK-385, Fluconazole, Atorvastatin
- Medical subject headings
- Prostatic Neoplasms, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAK-385Drug
TAK-385 tablets
FluconazoleDrug
Fluconazole tablets
AtorvastatinDrug
Atorvastatin tablets
| Study group | Role | What they receive |
|---|---|---|
| TAK-385 + fluconazole | Experimental | TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14. Receives: Drug: TAK-385; Drug: Fluconazole |
| TAK-385 + atorvastatin | Experimental | TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14. Receives: Drug: TAK-385; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1
Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1 (Predose and multiple time points up to 120 hours postdose)
Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10
Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 10 (Predose and multiple time points up to 120 hours postdose)
AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1
Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.
Measured: Day 1 (Predose and multiple time points up to 120 hours postdose)
AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10
Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.
Measured: Day 10 (Predose and multiple time points up to 120 hours postdose)
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1
Area under the plasma concentration-time curve from time 0 to infinity.
Measured: Day 1 (Predose and multiple time points up to 120 hours postdose)
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10
Area under the plasma concentration-time curve from time 0 to infinity.
Measured: Day 10 (Predose and multiple time points up to 120 hours postdose)
Secondary outcomes (11)
Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)
An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Measured: First dose of study drug through the end of the study (22 days ± 3 days)
Number of Participants With Clinical Significant Changes in Vital Signs
Vital sign measurements included oral temperature, heart rate, supine (after 3 to 5 minutes in this position) and standing (after 3 to 5 minutes in this position) measurements of diastolic and systolic blood pressure.
Measured: Baseline and First dose of study drug through the end of the study (22 days ± 3 days)
Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings
A 12-lead ECG was administered on Days 1,9,10,11,15.
Measured: Baseline and First dose of study drug through Day 15
Number of Participants With Clinical Significant Changes in Laboratory Tests
Blood samples were collected for analysis of clinical chemistry and hematological parameters and urine samples were obtained for urinalysis. Clinical laboratory evaluations were performed at central and /local laboratories.
Measured: Baseline and First dose of study drug through the end of the study (22 days ± 3 days)
Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385
Tmax is the time to reach the maximum concentrations (Cmax), equal to time (hours) to Cmax.
Measured: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385
Area under the plasma concentration versus time curve from 0 to 120 hours after study drug administration.
Measured: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Terminal Disposition Half-life (t1/2) of TAK-385
Terminal disposition half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Apparent Total Body Clearance (CL/F) of TAK-385
Measured: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Fraction Excreted Unchanged (Fe) of TAK-385
Fraction of TAK-385 excreted in the urine unchanged.
Measured: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Plasma Trough Concentrations for Fluconazole
Blood samples for fluconazole trough levels were collected predose (before dosing with fluconazole and before breakfast) on Days 8 through 12.
Measured: Days 8 to 12 Predose
Plasma Trough Concentrations for Atorvastatin
Blood samples for atorvastatin trough levels were collected predose (before dosing with atorvastatin and before breakfast) on Days 8 through 12.
Measured: Days 8 to 12 Predose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093390
- Sponsor's protocol ID
- C27005
- Other IDs
- U1111-1183-0138
- Status last verified
- Jun 2016
- First submitted
- 19 Mar 2014
- Last updated
- 6 Jun 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Multiple Oral Doses of Fluconazole and Atorvastatin on the Pharmacokinetics of a Single Oral Dose of TAK-385 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02093390
- Acronym / sponsor ID
- C27005
- Conditions
- Prostate Cancer, Endometriosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Mar 2014 (estimated)
- Results
- Posted 6 Jun 2016
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 nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.
Detailed description
The drug being tested in this study is called TAK-385. TAK-385 was being tested to assess if the way it is processed the body changes when it administered with other medications (fluconazole or atorvastatin). This study looked at lab results in people who took TAK-385.
The study enrolled 40 patients. Participants were assigned to one of the two treatment groups:
- TAK-385 40 mg and fluconazole 400 mg on Day 6 and 200 mg on Days 7 to 14
- TAK-385 40 mg and atorvastatin 80 mg on Days 6-14
Participants in the fluconazole arm were administered TAK-385 on Days 1 and 10 and fluconazole on Days 6 through 14. Participants in the atorvastatin arm were administered TAK-385 on Days 1 and 10 and atorvastatin on Days 6 through 14.
This single-center trial was conducted in the United States. The overall time to participate in this study was 4 weeks. Participants made multiple visits to the clinic, including one 16-day period of confinement to the clinic, and a final visit 7 days after last dose of study drug for a follow-up assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAK-385 + fluconazole | Experimental | Drug: TAK-385, Drug: FluconazoleTAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14. |
| TAK-385 + atorvastatin | Experimental | Drug: TAK-385, Drug: AtorvastatinTAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Age 18 to 55 years, inclusive, at the time of consent.
- Healthy adult male or female in good health, as determined by a physician evaluation
- Weight ≥ 45 kg and body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive, at screening.
- Nonsmoker and does not use tobacco-containing products (including, but not limited to, cigarettes, pipes, cigars, chewing tobacco, or nicotine patch or gum).
- Exclusion Criteria Subjects meeting any of the following exclusion criteria are not to be enrolled in the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TAK-385TAK-385 tablets | Drug | TAK-385 + atorvastatin, TAK-385 + fluconazole |
| FluconazoleFluconazole tablets | Drug | TAK-385 + fluconazole |
| AtorvastatinAtorvastatin tablets | Drug | TAK-385 + atorvastatin |
Primary outcome
Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 1
Time frame: Day 1 (Predose and multiple time points up to 120 hours postdose)
Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Cmax: Maximum Observed Plasma Concentration of TAK-385 on Day 10
Time frame: Day 10 (Predose and multiple time points up to 120 hours postdose)
Cmax is the peak concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 1
Time frame: Day 1 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.
AUC(0-tlast): Area Under the Plasma Concentration Curve From Time Zero to the Time of the Last Quantifiable Concentration of TAK-385 on Day 10
Time frame: Day 10 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration versus time curve from zero to the time of the last quantifiable concentration.
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 1
Time frame: Day 1 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration-time curve from time 0 to infinity.
AUC(0-inf): Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity of TAK-385 on Day 10
Time frame: Day 10 (Predose and multiple time points up to 120 hours postdose)
Area under the plasma concentration-time curve from time 0 to infinity.
11 secondary outcomes
Number of Participants With at Least 1 Treatment Emergent Adverse Event (AE)
Time frame: First dose of study drug through the end of the study (22 days ± 3 days)
Number of Participants With Clinical Significant Changes in Vital Signs
Time frame: Baseline and First dose of study drug through the end of the study (22 days ± 3 days)
Number of Participants With Clinical Significant Changes in Electrocardiogram (ECG) Findings
Time frame: Baseline and First dose of study drug through Day 15
Number of Participants With Clinical Significant Changes in Laboratory Tests
Time frame: Baseline and First dose of study drug through the end of the study (22 days ± 3 days)
Tmax: Time to Reach the Maximum Plasma Concentration of TAK-385
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
AUC (0-120): Area Under the Plasma Concentration-Time Curve From Time 0 to 120 Hours of TAK-385
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Terminal Disposition Half-life (t1/2) of TAK-385
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Apparent Total Body Clearance (CL/F) of TAK-385
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Fraction Excreted Unchanged (Fe) of TAK-385
Time frame: Days 1 and 10 (Predose and multiple time points up to 120 hours postdose)
Plasma Trough Concentrations for Fluconazole
Time frame: Days 8 to 12 Predose
Plasma Trough Concentrations for Atorvastatin
Time frame: Days 8 to 12 Predose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TAK-385, Fluconazole and Atorvastatin in people with Prostate Cancer and Endometriosis, run by Millennium Pharmaceuticals, Inc..
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 16 inclusion and 0 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 6 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 6 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Maximum Observed Plasma Concentration of TAK-385 on Day 1 (time frame: Day 1 (Predose and multiple time points up to 120 hours postdose)). The study lists 6 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 6 Jun 2016; AzTrials last refreshed its copy on 2 Nov 2026.