HealthyPhase 1BKP-1003-101NCT01581242

A Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects

A Phase 1 study testing Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil, Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil and Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil in people with Healthy, run by Bukwang Pharmaceutical 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

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Trial summary

This is a randomized, open-label, three-sequence, three-period, three-treatment clinical trial to investigate the pharmacokinetic drug-drug interaction of Clevudin and Adefovir dipivoxil after oral administration in healthy male subjects. Read more about this study

Who is it for?: Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil, Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil and Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteSouth Korea
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 20 to 45 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Age limit is from 20 to 45 with healthy male subjects in screening
Weight limit is from 50kg(110.23Ib) to 90kg(198.41Ib) with BMI 18.5-26 (BMI(kg/m2)= weight(kg)/{height(m)}2
The person who fully understands and listens about this clinical trial, receives written consent to observe the notandum and decides to participate voluntarily

Who cannot join

The person who has past history or serious disease in liver, kidney, nervous system, respiratory system, gastro-intestinal tract system, endocrine system, blood tumor, cardio-vascular system, urinary system, mental system clinically
The person who has the past history of Gastro-intestinal operation(except simple appendectomy or herniotomy)or Gastro-intestinal system disease (Chron's disease,ulcer,acute and chronic pancreatitis, etc) that can be influenced the absorption of clinical drug
The person who has the past history of hypersensitivity reaction about the drugs that contain the identical affiliation ingredient or ingredient of Clevudine, Adefovir dipivoxil or others drugs(aspirin, antibiotics etc)or has the significant past history of hypersensitivity reaction clinically
The person who shows results of the 1.5 times upper limit in screening test of AST(SGOT), ALT(SGPT)
The person who shows results of the positive HBsAg, HCV Ab,HIV Ab
The person who has a past history of drug abuse or shows a positive result of drug abuse in urine drug analysis of screening test

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The person who takes medications of some medicine and medical supplies or oriental medicine within 2 weeks before the first administration date', or some OTC drug, vitamin supplements or health functional food within 1week (if only,it's confirmed by the investigator's judgment that they are not affected in pharmacokinetics character and safety evaluation about the clinical drugs)
The person who participates in other clinical trials within 2 weeks before the first administration date'
The person who donates plasma pheresis within 1 month before the first administration date, donates whole blood within 2 months before the first administration date or receives a transfusion within a month before the first administration date
Persistent drinker(over 21 units/week, 1 unit = 10g of pure alcohol) or a drinker who can't stop drinking during hospitalization period
Smoker who takes a drag over 10 cigarettes per day during the past three months
The person who was judged unfit for participating in clinical trials by a investigator because of the clinical laboratory test results or other reasons

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Clinical Trial Center, Seoul National University Hospital
Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Three-sequence, Three-period, Three-treatment Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects

Read the detailed description

To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects

Conditions: Healthy
Being tested: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil, Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil, Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
Keywords: Clevudine and Adefovir dipivoxil, pharmacokinetic drug drug interaction, oral administration, male subjects

What participants receive

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

Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxilDrug
Clevudine 20mg qd Days 1; Adefovir dipivoxil 10 mg qd Days 8;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 15
Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxilDrug
Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 1; Clevudine 20mg qd Days 8; Adefovir dipivoxil 10 mg qd Days 15;
Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxilDrug
Adefovir dipivoxil 10 mg qd Days 1;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 8; Clevudine 20mg qd Days 15

Study groups in NCT01581242
Study group	Role	What they receive
A	Experimental	Not described Receives: Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil
B	Experimental	Not described Receives: Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
C	Experimental	Not described Receives: Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil

What is being measured

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

AUClast
Measured: Predose ~24hrs
Cmax
Measured: Predose~24hrs

Secondary outcomes (5)

AUCinf
Measured: Predose~24hrs
Tmax
Measured: Predose~24hrs
T1/2
Measured: Predose~24hrs
CL/F
Measured: Predose~24hrs
Safety
clinically measured adverse events, abnormality of laboratory tests abnormality of vital signs,ECG e.t.c
Measured: Screening, predose, post 24h, Post-study visit

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 posted20 Apr 2012 (estimated)
Study startApr 2012
Primary completionJun 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 42 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01581242
Sponsor's protocol ID: BKP-1003
Acronym: BKP-1003-101
Status last verified: Sep 2012
First submitted: 18 Apr 2012
Last updated: 18 Sep 2012
Results posted: No
Data monitoring committee: No

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Three-sequence, Three-period, Three-treatment Clinical Trial to Investigate the Pharmacokinetic Drug-drug Interaction of Clevudine and Adefovir Dipivoxil After Oral Administration in Healthy Male Subjects
ClinicalTrials.gov ID: NCT01581242
Acronym / sponsor ID: BKP-1003-101 / BKP-1003
Conditions: Healthy
Keywords: Clevudine and Adefovir dipivoxil, pharmacokinetic drug drug interaction, oral administration, male subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (estimated)
Lead sponsor: Bukwang PharmaceuticalIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Jun 2012 (actual)
First posted: 20 Apr 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.

Detailed description

To evaluate the safety, drug-tolerance, pharmacokinetics of Clevudine or Adefovir monotherapy or Adefovir and Clevudine combination in healthy male subjects

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
A	Experimental	Drug: Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil
B	Experimental	Drug: Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil
C	Experimental	Drug: Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil

Who may qualify

Ages: 20 to 45 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age limit is from 20 to 45 with healthy male subjects in screening
Weight limit is from 50kg(110.23Ib) to 90kg(198.41Ib) with BMI 18.5-26 (BMI(kg/m2)= weight(kg)/{height(m)}2
The person who fully understands and listens about this clinical trial, receives written consent to observe the notandum and decides to participate voluntarily

Key exclusion criteria (12 listed)

The person who has past history or serious disease in liver, kidney, nervous system, respiratory system, gastro-intestinal tract system, endocrine system, blood tumor, cardio-vascular system, urinary system, mental system clinically
The person who has the past history of Gastro-intestinal operation(except simple appendectomy or herniotomy)or Gastro-intestinal system disease (Chron's disease,ulcer,acute and chronic pancreatitis, etc) that can be influenced the absorption of clinical drug
The person who has the past history of hypersensitivity reaction about the drugs that contain the identical affiliation ingredient or ingredient of Clevudine, Adefovir dipivoxil or others drugs(aspirin, antibiotics etc)or has the significant past history of hypersensitivity reaction clinically
The person who shows results of the 1.5 times upper limit in screening test of AST(SGOT), ALT(SGPT)
The person who shows results of the positive HBsAg, HCV Ab,HIV Ab

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
Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxilClevudine 20mg qd Days 1; Adefovir dipivoxil 10 mg qd Days 8;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 15	Drug	A
Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxilClevudine 20mg +Adefovir dipivoxil 10mg qd Days 1; Clevudine 20mg qd Days 8; Adefovir dipivoxil 10 mg qd Days 15;	Drug	B
Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxilAdefovir dipivoxil 10 mg qd Days 1;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 8; Clevudine 20mg qd Days 15	Drug	C

Primary outcome

AUClast
Time frame: Predose ~24hrs
Cmax
Time frame: Predose~24hrs

5 secondary outcomes

AUCinf
Time frame: Predose~24hrs
Tmax
Time frame: Predose~24hrs
T1/2
Time frame: Predose~24hrs
CL/F
Time frame: Predose~24hrs
Safety
Time frame: Screening, predose, post 24h, Post-study visit

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 18 Sep 2012.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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 12 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 18 Sep 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 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?

AUClast (time frame: Predose ~24hrs). The study lists 2 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 NCT01581242.

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 18 Sep 2012.