HypertensionPhase 1NCT02704702

A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects

A Phase 1 study testing Fimasartan, Rosuvastatin and Fimasartan + Rosuvastatin in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate the pharmacokinetics and safety of Fimasartan and rosuvastatin when coadministered or administered alone as a single dose or as multiple doses to healthy male subjects. Read more about this study

Who is it for?: Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: Fimasartan, Rosuvastatin and Fimasartan + Rosuvastatin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: No sites listed yet
Study dates: Mar 2016to Jun 2016
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 19 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Caucasian male 19-55 years of age.
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
Medically healthy with no clinically significant medical history.
Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Who cannot join

History or presence of clinically significant medical or psychiatric condition or disease.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
Plasma donation within 7 days prior to the first dose of study drug.
Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

About this study

Read the detailed description

This is an open-label, randomized, 6-sequence, 3-period, 3-way crossover study. Within each period, randomized subjects will be 2 dosing regimens with the same drug(fimasartan or rosuvastatin) or study drug combination(fimasartan+rosuvastatin) on day 1 and quaque die(qd) from day 4 to day 10. After day 1 and day 10 dosing will be followed by pharmacokinetic sampling for 48 hours or 72 hours.

Conditions: Hypertension
Being tested: Fimasartan, Rosuvastatin, Fimasartan + Rosuvastatin
Keywords: Fimasartan
Medical subject headings: Hypertension

What participants receive

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

FimasartanDrug
RosuvastatinDrug
Fimasartan + RosuvastatinDrug

Study groups in NCT02704702
Study group	Role	What they receive
Sequence 1 (ABC)	Other	Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C) There will be a washout of at least 7 days between the each period. Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin
Sequence 2 (ACB)	Other	Period 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin
Sequence 3 (BAC)	Other	Period 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3) There will be a washout of at least 7 days between the each period. Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin
Sequence 4 (BCA)	Other	Period 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin
Sequence 5 (CAB)	Other	Period 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period. Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin
Sequence 6 (CBA)	Other	Period 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period. Receives: Drug: Fimasartan; Drug: Rosuvastatin; Drug: Fimasartan + Rosuvastatin

What is being measured

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

Area Under the Concentration-time Curve
This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method
Measured: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
Maximum Observed Concentration
This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.
Measured: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
Time to Reach Maximum Observed Plasma Concentration
This Outcome is the time it takes a drug to reach Cmax
Measured: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period

Timeline

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

Mar 2016Jun 2016

First posted10 Mar 2016 (estimated)
Study startMar 2016
Primary completionJun 2016
Study completionJun 2016

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 HypertensionStudies of the same condition, open and under way.
More trials run by Boryung Pharmaceutical Co., LtdThe 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
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02704702
Sponsor's protocol ID: BR-FRC-CT-102
Other IDs: CA16652
Status last verified: Feb 2018
First submitted: 4 Mar 2016
Last updated: 2 Nov 2018
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Rosuvastatin in Healthy Male Subjects
ClinicalTrials.gov ID: NCT02704702
Acronym / sponsor ID: BR-FRC-CT-102
Conditions: Hypertension
Keywords: Fimasartan
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: Boryung Pharmaceutical Co., LtdIndustry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: Jun 2016 (actual)
Study completion: Jun 2016 (actual)
First posted: 10 Mar 2016 (estimated)
Results: Posted 2 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence 1 (ABC)	Other	Drug: Fimasartan, Drug: Rosuvastatin, Drug: Fimasartan + RosuvastatinPeriod 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment C) There will be a washout of at least 7 days between the each period.
Sequence 2 (ACB)	Other	Drug: Fimasartan, Drug: Rosuvastatin, Drug: Fimasartan + RosuvastatinPeriod 1(Treatment A) → Period 2(Treatment C) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period.
Sequence 3 (BAC)	Other	Drug: Fimasartan, Drug: Rosuvastatin, Drug: Fimasartan + RosuvastatinPeriod 1(Treatment A) → Period 2(Treatment B) → Period 3(Treatment 3) There will be a washout of at least 7 days between the each period.
Sequence 4 (BCA)	Other	Drug: Fimasartan, Drug: Rosuvastatin, Drug: Fimasartan + RosuvastatinPeriod 1(Treatment B) → Period 2(Treatment C) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period.
Sequence 5 (CAB)	Other	Drug: Fimasartan, Drug: Rosuvastatin, Drug: Fimasartan + RosuvastatinPeriod 1(Treatment C) → Period 2(Treatment A) → Period 3(Treatment B) There will be a washout of at least 7 days between the each period.
Sequence 6 (CBA)	Other	Drug: Fimasartan, Drug: Rosuvastatin, Drug: Fimasartan + RosuvastatinPeriod 1(Treatment C) → Period 2(Treatment B) → Period 3(Treatment A) There will be a washout of at least 7 days between the each period.

Who may qualify

Ages: 19 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Caucasian male 19-55 years of age.
Body mass index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 at screening.
Medically healthy with no clinically significant medical history.
Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Key exclusion criteria (5 listed)

History or presence of clinically significant medical or psychiatric condition or disease.
Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
Seated blood pressure is less than 90/60 mmHg or greater than 140/90 mmHg at screening.
Plasma donation within 7 days prior to the first dose of study drug.
Participation in another clinical trial within 28 days prior to the first dose of study drug(s).

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
Fimasartan	Drug	Sequence 1 (ABC), Sequence 2 (ACB), Sequence 3 (BAC), Sequence 4 (BCA), Sequence 5 (CAB), Sequence 6 (CBA)
Rosuvastatin	Drug	Sequence 1 (ABC), Sequence 2 (ACB), Sequence 3 (BAC), Sequence 4 (BCA), Sequence 5 (CAB), Sequence 6 (CBA)
Fimasartan + Rosuvastatin	Drug	Sequence 1 (ABC), Sequence 2 (ACB), Sequence 3 (BAC), Sequence 4 (BCA), Sequence 5 (CAB), Sequence 6 (CBA)

Primary outcome

Area Under the Concentration-time Curve
Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
This Outcome is the Area Calculated using the Linear Trapezoidal with Linear Interpolation Method
Maximum Observed Concentration
Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
This Outcome is the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated.
Time to Reach Maximum Observed Plasma Concentration
Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period
This Outcome is the time it takes a drug to reach Cmax

Results and safety

Results posted to the registry on 2 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1 (ABC)	6	5
Sequence 2 (ACB)	6	6
Sequence 3 (BAC)	6	6
Sequence 4 (BCA)	6	5
Sequence 5 (CAB)	6	4
Sequence 6 (CBA)	6	4

Primary outcome: Area Under the Concentration-time Curve

Time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period. Geometric mean (95% Confidence Interval). Unit: ng*hr/mL

Measure	Treatment A(Single Dose) n = 34	Treatment A(Multiple Dose) n = 32	Treatment B(Single Dose) n = 35	Treatment B(Multiple Dose) n = 32	Treatment C(Single Dose_Fimasartan) n = 34	Treatment C(Single Dose_Rosuvastatin) n = 34	Treatment C(Multiple Dose_Fimasartan) n = 34	Treatment C(Multiple Dose_Rosuvastatin) n = 34
Value	690.43 (645.39 to 809.51)	820.86 (757.50 to 980.63)	86.442 (82.210 to 105.59)	114.55 (106.95 to 138.50)	702.20 (653.05 to 830.43)	85.078 (78.638 to 115.45)	880.19 (819.63 to 1018.7)	98.957 (91.971 to 120.50)

Primary outcome: Maximum Observed Concentration

Measure	Treatment A(Single Dose) n = 34	Treatment A(Multiple Dose) n = 32	Treatment B(Single Dose) n = 35	Treatment B(Multiple Dose) n = 32	Treatment C(Single Dose_Fimasartan) n = 34	Treatment C(Multiple Dose_Fimasartan) n = 34	Treatment C(Single Dose_Rosuvastatin) n = 34	Treatment C(Multiple Dose_Rosuvastatin) n = 34
Value	289.12 (272.28 to 373.86)	362.14 (339.10 to 523.63)	9.305 (8.755 to 11.733)	11.706 (10.927 to 14.416)	283.73 (268.35 to 383.63)	341.92 (329.13 to 462.35)	12.581 (11.697 to 17.502)	13.687 (12.713 to 17.300)

Primary outcome: Time to Reach Maximum Observed Plasma Concentration

Measure	Treatment A(Single Dose) n = 34	Treatment A(Multiple Dose) n = 32	Treatment B(Single Dose) n = 36	Treatment B(Multiple Dose) n = 32	Treatment C(Single Dose_Fimasartan) n = 34	Treatment C(Multiple Dose_Fimasartan) n = 34	Treatment C(Single Dose_Rosuvastatin) n = 34	Treatment C(Multiple Dose_Rosuvastatin) n = 34
Value	0.749 (0.50 to 2.00)	0.635 (0.49 to 2.51)	2.999 (1.00 to 5.03)	4.505 (1.01 to 5.06)	0.750 (0.50 to 1.50)	0.751 (0.50 to 4.00)	2.003 (1.00 to 5.00)	1.506 (1.00 to 5.09)

Adverse events

Time frame: Participants assessed 13 days for each intervention, a total of approximately 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment A(Single Dose)	0 of 34 (0%)	2 of 34 (5.9%)	0 of 34
Treatment A(Multiple Dose)	0 of 33 (0%)	6 of 33 (18.2%)	0 of 33
Treatment B(Single Dose)	0 of 35 (0%)	6 of 35 (17.1%)	0 of 35
Treatment B(Multiiple Dose)	1 of 34 (2.9%)	7 of 34 (20.6%)	0 of 34
Treatment C(Single Dose)	0 of 34 (0%)	6 of 34 (17.6%)	0 of 34
Treatment C(Multiple Dose)	0 of 34 (0%)	8 of 34 (23.5%)	0 of 34

Limitations and caveats (from the sponsor): Several sampling time deviations occurred during the clinical conduct of this study. Actual sampling times relative to dosing time were used for caculation of PK parameters.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
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.

Laura Sterling, M.D principal investigator

Celelion, Inc.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fimasartan, Rosuvastatin and Fimasartan + Rosuvastatin in people with Hypertension, run by Boryung Pharmaceutical Co., Ltd.

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 4 inclusion and 5 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 2 Nov 2018. 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 2 Nov 2018). 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?

Area Under the Concentration-time Curve (time frame: For Fimasartan PK(Treatment A and C) : Post-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 36, 48 in each period/For Rosuvastatin PK(Treatment B and C) : Post-dose, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72 in each period). The study lists 3 primary outcomes in all. 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 NCT02704702.

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 2 Nov 2018.