Trial · NCT02634073
A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
NCT02634073, Phase 4, Completed, ViiV Healthcare; results first posted 2017-05-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers. Trials, record NCT02634073. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02634073
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase IV, Open Label, 4-period Cross-over Study to Investigate a Drug Interaction Between Lamivudine and Sorbitol Oral Solutions in Healthy Volunteers
- NCT number
- NCT02634073
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 16 participants, actual
- Lead sponsor
- ViiV Healthcare
- Conditions
- Infection, Human Immunodeficiency Virus
- Interventions
- Lamivudine, Sorbitol
- First posted
- 2015-12-17
- Last updated
- 2017-05-15
- Results first posted
- 2017-05-15
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | Day 1 to Day 3 in each treatment period | Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. AUC was determined using the trapezoidal rule. Analysis of variance (ANOVA), considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine Pharmacokinetic (PK) parameters. |
| Primary | Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct) | Day 1 to Day 3 in each treatment period | Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. Time of the last measurable concentration (t) was 48 hours for all participants and all treatments. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine PK parameters. |
| Primary | Lamivudine Elimination Half-life in Plasma (t1/2) | Day 1 to Day 3 in each treatment period | Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine t1/2. |
| Primary | Plasma Lamivudine Apparent Oral Clearance (CL/F) | Day 1 to Day 3 in each treatment period | Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. ANOVA, considering treatment and period as fixed effects and participant as random effect, was performed using Mixed Linear Models procedure to compare the plasma lamivudine CL/F |
| Primary | Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag) | Day 1 to Day 3 in each treatment period | Serial blood sample were collected at Pre-dose; 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 16, 24, 36 and 48 hours post-dose in each treatment period. |
| Secondary | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE) | Up to 5 Weeks | An AE is any untoward medical occurrence, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect or event that may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition. |
| Secondary | Change From Baseline in Pulse Rate | Baseline and up to 5 weeks | Change from Baseline for pulse rate was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. |
| Secondary | Change From Baseline in Body Temperature | Baseline and up to 5 weeks | Change from Baseline for body temperature was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to 5 weeks | Change from Baseline for DBP and SBP was calculated as the post-dose visit value minus the value at Baseline, at Day 3 and Follow-up. Baseline value used in the analysis was the latest pre-dose values on Day 1 of each treatment/period. |
| Secondary | Number of Participants With Treatment Emergent Laboratory Abnormality Grade | Up to Week 5 | Division of Acquired immune deficiency syndrome (DAIDS) Table AE grades 1, 2, 3, and 4 of laboratory abnormalities were applied and grade were summarized by treatment and day and were listed by participant, treatment, day, and actual date and time. Treatment emergent grades are defined as any new toxicity grades or the worsened grades compared to Baseline grade. Treatment emergent lab abnormality Grade 1 for aspartate aminotransferase and sodium at follow-up visit are summarized. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | Day 1 to Day 3 in each treatment period | PK Summary Population: defined as participants who had valid lamivudine PK parameter estimates from both reference and test treatments. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | hour (h)*microgram (mcg)/milliliter (mL) | GEOMETRIC_MEAN |
| PRIMARY | Plasma Lamivudine Maximum Observed Concentration (Cmax), Concentration at 24 Hour (h) Post-dose (C24) and Last Measurable Concentration (Ct) | Day 1 to Day 3 in each treatment period | mcg/mL | GEOMETRIC_MEAN | |
| PRIMARY | Lamivudine Elimination Half-life in Plasma (t1/2) | Day 1 to Day 3 in each treatment period | PK Summary Population | Hour (Hr) | GEOMETRIC_MEAN |
| PRIMARY | Plasma Lamivudine Apparent Oral Clearance (CL/F) | Day 1 to Day 3 in each treatment period | PK Summary Population | Liter (L)/hr | GEOMETRIC_MEAN |
| PRIMARY | Time to Observed Maximum Lamivudine Plasma Concentration (Tmax), Time of Last Measurable Plasma Concentration (Tlast) and Absorption Lag Time in Plasma (Tlag) | Day 1 to Day 3 in each treatment period | Hr | MEDIAN | |
| SECONDARY | Number of Participants With Any Adverse Events (AEs) and Any Serious Adverse Events (SAE) | Up to 5 Weeks | Safety Population: defined as all participants who enrolled into the study and received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Pulse Rate | Baseline and up to 5 weeks | Safety Population.Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | Beats/min | MEAN |
| SECONDARY | Change From Baseline in Body Temperature | Baseline and up to 5 weeks | Safety Population | Degree centigrade | MEAN |
| SECONDARY | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) | Baseline and up to 5 weeks | Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). | millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Laboratory Abnormality Grade | Up to Week 5 | Safety Population | Participants | NUMBER |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group268
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | A: Lamivudine 300 mg | AUC (0-inf); n=16, 14, 16, 13 | 13.2 | Geometric Coefficient of Variation 22.3 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | B: Lamivudine 300 mg + Sorbitol 3.2 g | AUC (0-inf); n=16, 14, 16, 13 | 11.3 | Geometric Coefficient of Variation 21.2 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | C: Lamivudine 300 mg + Sorbitol 10.2 g | AUC (0-inf); n=16, 14, 16, 13 | 8.93 | Geometric Coefficient of Variation 22.1 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | D: Lamivudine 300 mg + Sorbitol 13.4 g | AUC (0-inf); n=16, 14, 16, 13 | 8.60 | Geometric Coefficient of Variation 24.1 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | A: Lamivudine 300 mg | AUC (0-24) ; n=16, 16, 16, 16 | 12.4 | Geometric Coefficient of Variation 23.6 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | B: Lamivudine 300 mg + Sorbitol 3.2 g | AUC (0-24) ; n=16, 16, 16, 16 | 9.96 | Geometric Coefficient of Variation 22.6 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | C: Lamivudine 300 mg + Sorbitol 10.2 g | AUC (0-24) ; n=16, 16, 16, 16 | 7.54 | Geometric Coefficient of Variation 23.7 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | D: Lamivudine 300 mg + Sorbitol 13.4 g | AUC (0-24) ; n=16, 16, 16, 16 | 6.91 | Geometric Coefficient of Variation 28.9 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | A: Lamivudine 300 mg | AUC (0-t) ; n=16, 16, 16, 16 | 12.9 | Geometric Coefficient of Variation 23.0 | hour (h)*microgram (mcg)/milliliter (mL) |
Plasma Lamivudine Area Under the Plasma Concentration Time Curve (AUC) From Time Zero to the Last Quantifiable Time Point (AUC[0-t]), AUC From Time Zero Extrapolated to Infinity (AUC[0-inf]) and AUC From Time Zero to 24 Hours (AUC[0-24]) | B: Lamivudine 300 mg + Sorbitol 3.2 g | AUC (0-t) ; n=16, 16, 16, 16 | 10.6 | Geometric Coefficient of Variation 21.6 | hour (h)*microgram (mcg)/milliliter (mL) |
1 to 10 of 268Source ClinicalTrials.gov
See all 268 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Sequence 1: ADBC | 4 | |
| Overall Study | STARTED | Treatment Sequence 2: BACD | 4 | |
| Overall Study | STARTED | Treatment Sequence 3: CBDA | 4 | |
| Overall Study | STARTED | Treatment Sequence 4: DCAB | 4 | |
| Overall Study | COMPLETED | Treatment Sequence 1: ADBC | 4 | |
| Overall Study | COMPLETED | Treatment Sequence 2: BACD | 4 | |
| Overall Study | COMPLETED | Treatment Sequence 3: CBDA | 4 | |
| Overall Study | COMPLETED | Treatment Sequence 4: DCAB | 4 | |
| Overall Study | NOT COMPLETED | Treatment Sequence 1: ADBC | 0 | |
| Overall Study | NOT COMPLETED | Treatment Sequence 2: BACD | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastroenteritis | Infections and infestations | A: Lamivudine 300 mg | 0 | 16 | |
| other | Gastroenteritis | Infections and infestations | B: Lamivudine 300 mg + Sorbitol 3.2 g | 1 | 16 | |
| other | Gastroenteritis | Infections and infestations | C: Lamivudine 300 mg + Sorbitol 10.2 g | 0 | 16 | |
| other | Gastroenteritis | Infections and infestations | D: Lamivudine 300 mg + Sorbitol 13.4 g | 0 | 16 | |
| other | Vaginal infection | Infections and infestations | A: Lamivudine 300 mg | 0 | 16 | |
| other | Vaginal infection | Infections and infestations | B: Lamivudine 300 mg + Sorbitol 3.2 g | 0 | 16 | |
| other | Vaginal infection | Infections and infestations | C: Lamivudine 300 mg + Sorbitol 10.2 g | 0 | 16 | |
| other | Vaginal infection | Infections and infestations | D: Lamivudine 300 mg + Sorbitol 13.4 g | 1 | 16 | |
| other | Vessel puncture site pain | General disorders | A: Lamivudine 300 mg | 0 | 16 | |
| other | Vessel puncture site pain | General disorders | B: Lamivudine 300 mg + Sorbitol 3.2 g | 1 | 16 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A: Lamivudine 300 mg | ||
| Total, all-cause mortality | B: Lamivudine 300 mg + Sorbitol 3.2 g | ||
| Total, all-cause mortality | C: Lamivudine 300 mg + Sorbitol 10.2 g | ||
| Total, all-cause mortality | D: Lamivudine 300 mg + Sorbitol 13.4 g | ||
| Total, other adverse events | A: Lamivudine 300 mg | 1 | 16 |
| Total, other adverse events | B: Lamivudine 300 mg + Sorbitol 3.2 g | 2 | 16 |
| Total, other adverse events | C: Lamivudine 300 mg + Sorbitol 10.2 g | 1 | 16 |
| Total, other adverse events | D: Lamivudine 300 mg + Sorbitol 13.4 g | 1 | 16 |
| Total, serious adverse events | A: Lamivudine 300 mg | 0 | 16 |
| Total, serious adverse events | B: Lamivudine 300 mg + Sorbitol 3.2 g | 0 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29150845 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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