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Lamivudine

Phase 1

Hepatitis B, Chronic | Small molecule | Infectious Disease |GSK plc|Last Updated: Aug 4, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Lamivudine · 1 trial · 1 indication

Phase 1 1
NCT01353742Lamivudine and Adefovir Dipivoxil Fixed Dose CombinationHepatitis B, Chronic
COMPLETED40 Analytics
PHASE1COMPLETED
Lamivudine and Adefovir Dipivoxil Fixed Dose Combination
Hepatitis B, Chronic
NCT0135374240
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Study Endpoints

Primary Endpoints

AUC of lamivudine
48 hours
Cmax of lamivudine
48 hours
AUC of adefovir dipivoxil
48 hours
Cmax of adefovir dipivoxil
48 hours

Secondary Endpoints

PK parameters: t1/2 of lamivudine
48 hours
Tolerability will be assessed by clinical data from Adverse Event reporting, nurse/physician observations, vital signs, ECGs, and clinical laboratory.
48 hours
PK parameters: Tmax of lamivudine
48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Lamivudine and Adefovir dipivoxilACTIVE_COMPARATOROne 100mg Lamivudine tablet and One 10mg Adefovir dipivoxil tablet
Fixed dose combinationEXPERIMENTALOne capsule (100mg lamivudine and 10mg adefovir dipivoxil)

Interventions

NameTypeDescription
LamivudineDRUG100mg tablet
Adefovir dipivoxilDRUG10mg tablet
Fixed dose combination (Lamivudine and Adefovir dipivoxil)DRUG100mg/10mg capsule
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy as determined by a responsible physician. * Male 18 and 55 years of age. * Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods. * Body weight \>50 kg (110 lbs) and body mass index (BMI) between 19.0 and 25.0....

Countries:Hong Kong
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Frequently asked questions about Lamivudine

What is Lamivudine used for in Hepatitis B, Chronic?

Lamivudine is a small molecule being studied for the treatment of chronic Hepatitis B. It is currently in Phase 1 clinical development as an investigational therapy. The drug is being evaluated in a clinical trial involving patients with this condition, though it is not yet approved for this use.

Who makes Lamivudine?

Lamivudine is being developed by GSK plc, a pharmaceutical company listed on the stock exchange under the ticker GSK. The company is conducting clinical research to evaluate the drug's safety and efficacy in treating chronic Hepatitis B.

What phase is Lamivudine in?

Lamivudine is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing clinical program is focused on assessing the drug's safety and pharmacokinetics in early-stage trials.

What clinical trials is Lamivudine in?

Lamivudine has one completed clinical trial registered under NCT01353742, titled 'Lamivudine and Adefovir Dipivoxil Fixed Dose Combination'. This Phase 1 study enrolled 40 healthy male volunteers in Hong Kong and was active-controlled, though not double-blinded. The trial has been completed.

Is Lamivudine the same as a fixed-dose combination with Adefovir Dipivoxil?

Lamivudine is being studied as part of a fixed-dose combination with Adefovir Dipivoxil in the clinical trial NCT01353742. This combination is being evaluated for the treatment of chronic Hepatitis B. The trial is in Phase 1 and has been completed.