Hepatitis B, ChronicPhase 1PK of TDFNCT01480622
Pharmacokinetic (PK) Profiles of Tenofovir Disoproxil Fumarate (TDF) 300 mg in Healthy Chinese Subjects
A Phase 1 study testing TDF tablets in people with Hepatitis B, Chronic, run by GlaxoSmithKline at 1 site in China.
Trial summary
This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF) 300 mg in Chinese subjects to support the registration of this compound in the People's Republic of China. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- TDF tablets
- 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 siteChina
- Study dates
- 5 Dec 2011to 30 Dec 2011
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, as determined by a responsible and experienced physician
- Male or female between 18 and 45 years of age
- Body weight >50 kg (110 lbs) for males or >45 kg (100 lbs) for females, and body mass index (BMI) between 19.0 and 24.0 kg/m2
Who cannot join
- Positive result for hepatitis B, hepatitis C or HIV at screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Positive urine drug screen and breath alcohol test at screening or prior to dosing
- Lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label Single and Repeat Dose Study to Investigate the Pharmacokinetic Profiles of Tenofovir Disoproxil Fumarate 300 mg in Healthy Chinese Subjects
This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF) 300 mg in Chinese subjects to support the registration of this compound in the People's Republic of China. This will be an open-label, single group, single and repeat dose study without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after the single dose and at steady state. The duration of the study will be approximately 7 weeks from screening to follow-up.
Read the detailed description
This will be an open-label, single group, single and repeat dose study with no placebo control in healthy Chinese subjects conducted at a single centre. The study will include a screening visit, single and repeat dose sessions and a follow-up contact.
The screening visit will be conducted up to 28 days prior to the first dose of treatment period 1. Screening assessments will occur as indicated in the Time and Events Table.
Subjects who meet the inclusion/exclusion criteria will be admitted to the study centre on Day -1 to undergo baseline procedures before the single dose session. Study medication will be administered the following morning (Day 1) for the single dose phase. Subjects will be required to fast for at least 8 h (overnight) prior to dosing until 4 h after dosing. Pharmacokinetic samples will be taken until Day 3.
The repeat dose session will begin on Day 4. Subjects will receive a once daily dose of TDF 300 mg in a fasted state each morning for 7 days. Subjects will be required to fast for at least 8 h (overnight) prior to dosing on Day 8 and Day 9, and for at least 8 h (overnight) prior to dosing until 4 h after dosing on Day 10. A trough pharmacokinetic sample will be collected before dosing on Day 8, Day 9 and a series of samples will be taken from Day 10 to Day 12.
Subjects will remain in-house from the evening before dosing (Day -1) until after the final pharmacokinetic sample has been collected on Day 12 and the final safety assessment completed on Day 13. Then subjects will be discharged from the study centre at the Investigator's discretion.
Subjects completing the dosing sessions will not be required to visit the study centre for a follow-up visit, unless the Investigator determines that it is necessary for safety or other reasons. All subjects will receive a follow-up contact by telephone or visit 7 days after the last dosing to collect any information on concomitant medication taken and AEs experienced since the last visit.
The total duration of each subject's participation, from screening to follow-up contact, will be approximately 7 weeks.
- Conditions
- Hepatitis B, Chronic
- Being tested
- TDF tablets
- Keywords
- healthy subjects, Tenofovir disoproxil fumarate, hepatitis, pharmacokinetics
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDF tabletsDrug
White, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331"
| Study group | Role | What they receive |
|---|---|---|
| TDF tablets | Experimental | Tenofovir disoproxil fumarate tablets Receives: Drug: TDF tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))
AUC(0-t) of single dose
Measured: up to 60 hours after single dose
area under the concentration-time curve during steady state (AUC(0-τ))
AUC(0-τ) during steady state
Measured: up to 60 hours after repeat dose
Secondary outcomes (4)
adverse events (AEs)
AEs accur during the study
Measured: up to 20 days, from the first dose until the follow-up contact
vital signs
blood pressure, pulse rate, respiratory rate and temperature
Measured: day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
lab assessment
Haematology, Clinical Chemistry and Routine Urinalysis
Measured: day 13, prior to discharge from hospital
12-lead electrocardiogram (ECG) parameters
the heart rate and measures PR, QRS, QT and QTc intervals. All ECGs must be evaluated for safety by a qualified physician.
Measured: day 13, prior to discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study start5 Dec 2011
- Primary completion30 Dec 2011
- Study completion30 Dec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480622
- Sponsor's protocol ID
- 115515
- Acronym
- PK of TDF
- Status last verified
- Jun 2017
- First submitted
- 17 Nov 2011
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Hu CY, Liu YM, Liu Y, Chen Q, Wang W, Wu K, Dong J, Li J, Jia JY, Lu C, Sun SX, Yu C, Li X. Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily: an open-label, single- and multiple-dose study in healthy Chinese subjects. Clin Ther. 2013 Dec;35(12):1884-9. doi: 10.1016/j.clinthera.2013.09.020. Epub 2013 Oct 19.
PubMed 24148552
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Single and Repeat Dose Study to Investigate the Pharmacokinetic Profiles of Tenofovir Disoproxil Fumarate 300 mg in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT01480622
- Acronym / sponsor ID
- PK of TDF / 115515
- Conditions
- Hepatitis B, Chronic
- Keywords
- healthy subjects, Tenofovir disoproxil fumarate, hepatitis, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2011 (actual)
- Primary completion
- 30 Dec 2011 (actual)
- Study completion
- 30 Dec 2011 (actual)
- First posted
- 29 Nov 2011 (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.
This study will evaluate the pharmacokinetic profile of tenofovir disoproxil fumarate (TDF) 300 mg in Chinese subjects to support the registration of this compound in the People's Republic of China. This will be an open-label, single group, single and repeat dose study without placebo in healthy male and female subjects. Pharmacokinetic sampling to enable measurement of plasma concentrations of tenofovir will be conducted over a 60-h period after the single dose and at steady state. The duration of the study will be approximately 7 weeks from screening to follow-up.
Detailed description
This will be an open-label, single group, single and repeat dose study with no placebo control in healthy Chinese subjects conducted at a single centre. The study will include a screening visit, single and repeat dose sessions and a follow-up contact.
The screening visit will be conducted up to 28 days prior to the first dose of treatment period 1. Screening assessments will occur as indicated in the Time and Events Table.
Subjects who meet the inclusion/exclusion criteria will be admitted to the study centre on Day -1 to undergo baseline procedures before the single dose session. Study medication will be administered the following morning (Day 1) for the single dose phase. Subjects will be required to fast for at least 8 h (overnight) prior to dosing until 4 h after dosing. Pharmacokinetic samples will be taken until Day 3.
The repeat dose session will begin on Day 4. Subjects will receive a once daily dose of TDF 300 mg in a fasted state each morning for 7 days. Subjects will be required to fast for at least 8 h (overnight) prior to dosing on Day 8 and Day 9, and for at least 8 h (overnight) prior to dosing until 4 h after dosing on Day 10. A trough pharmacokinetic sample will be collected before dosing on Day 8, Day 9 and a series of samples will be taken from Day 10 to Day 12.
Subjects will remain in-house from the evening before dosing (Day -1) until after the final pharmacokinetic sample has been collected on Day 12 and the final safety assessment completed on Day 13. Then subjects will be discharged from the study centre at the Investigator's discretion.
Subjects completing the dosing sessions will not be required to visit the study centre for a follow-up visit, unless the Investigator determines that it is necessary for safety or other reasons. All subjects will receive a follow-up contact by telephone or visit 7 days after the last dosing to collect any information on concomitant medication taken and AEs experienced since the last visit.
The total duration of each subject's participation, from screening to follow-up contact, will be approximately 7 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDF tablets | Experimental | Drug: TDF tabletsTenofovir disoproxil fumarate tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy, as determined by a responsible and experienced physician
- Male or female between 18 and 45 years of age
- Body weight >50 kg (110 lbs) for males or >45 kg (100 lbs) for females, and body mass index (BMI) between 19.0 and 24.0 kg/m2
Key exclusion criteria (4 listed)
- Positive result for hepatitis B, hepatitis C or HIV at screening
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- Positive urine drug screen and breath alcohol test at screening or prior to dosing
- Lactating females
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 |
|---|---|---|
| TDF tabletsWhite, almond-shaped, film-coated tablets, one side with the markings "GILEAD" and "4331" | Drug | TDF tablets |
Primary outcome
area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t))
Time frame: up to 60 hours after single dose
AUC(0-t) of single dose
area under the concentration-time curve during steady state (AUC(0-τ))
Time frame: up to 60 hours after repeat dose
AUC(0-τ) during steady state
4 secondary outcomes
adverse events (AEs)
Time frame: up to 20 days, from the first dose until the follow-up contact
vital signs
Time frame: day 1 pre-dose, day 2, day 3, day 10 pre-dose, day 11, day 12 and day 13 prior to discharge from hospital
lab assessment
Time frame: day 13, prior to discharge from hospital
12-lead electrocardiogram (ECG) parameters
Time frame: day 13, prior to discharge from hospital
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 14 Jun 2017.
- Derived from this study: PubMed 24148552Hu CY, Liu YM, Liu Y, Chen Q, Wang W, Wu K, Dong J, Li J, Jia JY, Lu C, Sun SX, Yu C, Li X. Pharmacokinetics and tolerability of Tenofovir disoproxil fumarate 300 mg once daily: an open-label, single- and multiple-dose study in healthy Chinese subjects. Clin Ther. 2013 Dec;35(12):1884-9. doi: 10.1016/j.clinthera.2013.09.020. Epub 2013 Oct 19.
- Results for study 115515 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 TDF tablets in people with Hepatitis B, Chronic, run by GlaxoSmithKline at 1 site in China.
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 4 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 14 Jun 2017. 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 China. 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?
area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC(0-t)) (time frame: up to 60 hours after single dose). 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 NCT01480622, which also lists 1 linked publication.
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 14 Jun 2017.