HIV InfectionsPhase 1NCT04757974
Low-dose Fostemsavir Extended Release Relative Bioavailability Study
A Phase 1 study testing Fostemsavir 600 mg and Fostemsavir 200 mg in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
Trial summary
This is a two-part study. Part 1 will evaluate relative bioavailability of temsavir (TMR) following single dose administration of the reference fostemsavir (FTR) compared to two low-dose ER tablet formulations of FTR. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Fostemsavir 600 mg and Fostemsavir 200 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Mar 2021to 31 Jul 2021
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 50 years of age inclusive.
- Healthy as determined by the investigator or medically qualified designee.
- A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 50 kilograms (kg) (110 pounds [lbs.]) for men and >= 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-31.0 kilogram per meter square (kg/m^2) (inclusive).
- Male participants are eligible to participate if they agree to use contraceptive methods.
- A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP). OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective.
- Capable of giving signed informed consent.
Who cannot join
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
- Total bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 millisecond (msec) for males and QTcF>470 msec for females.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and ViiV/GlaxoSmithKline (GSK) Medical Monitor the medication will not interfere with the study procedures or compromise participant safety.
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- Participation in the study would result in loss of blood or blood products in excess of 500 milliliters (mL) within 56 days.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day.
- Current enrollment or past participation within the last 30 days or five half-lives whichever is longer, before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- Presence of hepatitis B surface antigen (HBsAg) [or hepatitis B core antibody (HBcAb)] at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C Ribonucleic acid (RNA) test result at screening or within 3 months prior to first dose of study intervention.
- Positive Human immunodeficiency virus (HIV)-1 and -2 antigen/antibody immunoassay.
- Cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Regular alcohol consumption within 6 months of the study defined as: An average weekly intake of >14 drinks for males or >7 drinks for females.
- Regular use of known drugs of abuse.
- Sensitivity to heparin or heparin-induced thrombocytopenia.
- Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study.
- A participant with a history of beta-lactam allergy, regardless of severity/seriousness.
- A participant with known or suspected active Coronavirus disease-2019 (COVID-19) infection OR contact with an individual with known COVID-19, within 14 days of study enrollment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two-Part Randomized Study to Evaluate the Relative Bioavailability of Temsavir Following Single Dose Administration of Fostemsavir 600 mg Tablets Compared to Two Fostemsavir 200 mg Tablet Formulations and to Evaluate the Effect of Food on Bioavailability of Selected Fostemsavir 200 mg Tablet Formulation in Healthy Adult Participants
This is a two-part study. Part 1 will evaluate relative bioavailability of temsavir (TMR) following single dose administration of the reference fostemsavir (FTR) compared to two low-dose ER tablet formulations of FTR. In Part 2, the effect of food on the bioavailability of TMR will be assessed on the selected low-dose ER tablet formulation from Part 1.
- Conditions
- HIV Infections
- Being tested
- Fostemsavir 600 mg, Fostemsavir 200 mg
- Keywords
- Temsavir, Fostemsavir, Bioavailability, Extended Release tablet, GSK3684934, Food effect
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostemsavir 600 mgDrug
Fostemsavir tablets will be administered via oral route.
Fostemsavir 200 mgDrug
Fostemsavir tablets will be administered via oral route.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Treatment sequence ABC | Experimental | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. Receives: Drug: Fostemsavir 600 mg; Drug: Fostemsavir 200 mg |
| Part 1: Treatment sequence BCA | Experimental | Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. Receives: Drug: Fostemsavir 600 mg; Drug: Fostemsavir 200 mg |
| Part 1: Treatment sequence CAB | Experimental | Participants will receive FTR 600 mg ER tablet in Period 1 (Treatment C, reference) followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. Receives: Drug: Fostemsavir 600 mg; Drug: Fostemsavir 200 mg |
| Part 1: Treatment sequence ACB | Experimental | Participants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. Receives: Drug: Fostemsavir 600 mg; Drug: Fostemsavir 200 mg |
| Part 1: Treatment sequence BAC | Experimental | Participants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. Receives: Drug: Fostemsavir 600 mg; Drug: Fostemsavir 200 mg |
| Part 1: Treatment sequence CBA | Experimental | Participants will receive FTR 600 mg ER tablet (Treatment C, reference) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. Receives: Drug: Fostemsavir 600 mg; Drug: Fostemsavir 200 mg |
| Part 2: Treatment sequence DE | Experimental | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets in a fasted state (Treatment D) in Period 1 and following a high fat high calorie meal (Treatment E) in Period 2. Receives: Drug: Fostemsavir 200 mg |
| Part 2: Treatment sequence ED | Experimental | Participants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets following a high fat high calorie meal (Treatment E) in Period 1 and in a fasted state (Treatment D) in Period 2. Receives: Drug: Fostemsavir 200 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Area under the plasma concentration-time curve (AUC) from time zero to the last quantifiable time point (AUC[0-t]) of temsavir
Measured: Predose (Day 1) until 72 hour post dose
Part 1: AUC from time zero extrapolated to infinite time (AUC[0-infinity]) of temsavir
Measured: Predose (Day 1) until 72 hour post dose
Part 1: Maximum observed plasma concentration (Cmax)
Measured: Predose (Day 1) until 72 hour post dose
Secondary outcomes (8)
Part 1: Time to Cmax (Tmax) of temsavir
Measured: Predose (Day 1) until 72 hour post dose
Part 1: Elimination half-life (T1/2) of temsavir
Measured: Predose (Day 1) until 72 hour post dose
Part 1: Concentration at 12 hours post-dose of temsavir
Measured: 12 hours post-dose
Part 1 and Part 2: Number of participants with clinically significant change from Baseline in vital signs and clinical laboratory parameters
Measured: Baseline (Day -1) until end of follow up at 4 weeks
Part 1 and Part 2: Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline (Day -1) until end of follow up at 4 weeks
Part 2: AUC [0-t] of temsavir
Measured: Predose (Day 1) until 72 hour post dose
Part 2: AUC [0-infinity] of temsavir
Measured: Predose (Day 1) until 72 hour post dose
Part 2: Cmax of temsavir
Measured: Predose (Day 1) until 72 hour post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start5 Mar 2021
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by ViiV HealthcareThe 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a two-part study, where Part 1 will be conducted as a randomized three period, three treatment crossover study and Part 2 will have a randomized two period, two treatment crossover design.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- ViiV Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, ViiV Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04757974
- Sponsor's protocol ID
- 213075
- Status last verified
- Sep 2021
- First submitted
- 12 Feb 2021
- Last updated
- 22 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD for this study will be made available via the Clinical Study Data Request site.
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Randomized Study to Evaluate the Relative Bioavailability of Temsavir Following Single Dose Administration of Fostemsavir 600 mg Tablets Compared to Two Fostemsavir 200 mg Tablet Formulations and to Evaluate the Effect of Food on Bioavailability of Selected Fostemsavir 200 mg Tablet Formulation in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT04757974
- Acronym / sponsor ID
- 213075
- Conditions
- HIV Infections
- Keywords
- Temsavir, Fostemsavir, Bioavailability, Extended Release tablet, GSK3684934, Food effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- ViiV HealthcareIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2021 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 17 Feb 2021 (actual)
- 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 is a two-part study. Part 1 will evaluate relative bioavailability of temsavir (TMR) following single dose administration of the reference fostemsavir (FTR) compared to two low-dose ER tablet formulations of FTR. In Part 2, the effect of food on the bioavailability of TMR will be assessed on the selected low-dose ER tablet formulation from Part 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 8
- Model description
- This is a two-part study, where Part 1 will be conducted as a randomized three period, three treatment crossover study and Part 2 will have a randomized two period, two treatment crossover design.
| Arm | Type | Receives |
|---|---|---|
| Part 1: Treatment sequence ABC | Experimental | Drug: Fostemsavir 600 mg, Drug: Fostemsavir 200 mgParticipants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
| Part 1: Treatment sequence BCA | Experimental | Drug: Fostemsavir 600 mg, Drug: Fostemsavir 200 mgParticipants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
| Part 1: Treatment sequence CAB | Experimental | Drug: Fostemsavir 600 mg, Drug: Fostemsavir 200 mgParticipants will receive FTR 600 mg ER tablet in Period 1 (Treatment C, reference) followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
| Part 1: Treatment sequence ACB | Experimental | Drug: Fostemsavir 600 mg, Drug: Fostemsavir 200 mgParticipants will receive FTR 3×200 mg ER tablets (Treatment A) in Period 1 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 3. |
| Part 1: Treatment sequence BAC | Experimental | Drug: Fostemsavir 600 mg, Drug: Fostemsavir 200 mgParticipants will receive FTR 3×200 mg ER tablets (Treatment B) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 2 followed by FTR 600 mg ER tablet (Treatment C, reference) in Period 3. |
| Part 1: Treatment sequence CBA | Experimental | Drug: Fostemsavir 600 mg, Drug: Fostemsavir 200 mgParticipants will receive FTR 600 mg ER tablet (Treatment C, reference) in Period 1 followed by FTR 3×200 mg ER tablets (Treatment B) in Period 2 followed by FTR 3×200 mg ER tablets (Treatment A) in Period 3. |
| Part 2: Treatment sequence DE | Experimental | Drug: Fostemsavir 200 mgParticipants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets in a fasted state (Treatment D) in Period 1 and following a high fat high calorie meal (Treatment E) in Period 2. |
| Part 2: Treatment sequence ED | Experimental | Drug: Fostemsavir 200 mgParticipants will receive the selected low-dose formulation of FTR 3 × 200 mg ER tablets following a high fat high calorie meal (Treatment E) in Period 1 and in a fasted state (Treatment D) in Period 2. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 to 50 years of age inclusive.
- Healthy as determined by the investigator or medically qualified designee.
- A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Body weight >= 50 kilograms (kg) (110 pounds [lbs.]) for men and >= 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-31.0 kilogram per meter square (kg/m^2) (inclusive).
- Male participants are eligible to participate if they agree to use contraceptive methods.
Key exclusion criteria (20 listed)
- History or presence of/significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention or interfering with the interpretation of data.
- Alanine transaminase (ALT) >1.5x upper limit of normal (ULN).
- Total bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%).
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- QT interval corrected for heart rate according to Fridericia's formula (QTcF) >450 millisecond (msec) for males and QTcF>470 msec for 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 |
|---|---|---|
| Fostemsavir 600 mgFostemsavir tablets will be administered via oral route. | Drug | Part 1: Treatment sequence ABC, Part 1: Treatment sequence ACB, Part 1: Treatment sequence BAC, Part 1: Treatment sequence BCA, Part 1: Treatment sequence CAB, Part 1: Treatment sequence CBA |
| Fostemsavir 200 mgFostemsavir tablets will be administered via oral route. | Drug | Part 1: Treatment sequence ABC, Part 1: Treatment sequence ACB, Part 1: Treatment sequence BAC, Part 1: Treatment sequence BCA, Part 1: Treatment sequence CAB, Part 1: Treatment sequence CBA, Part 2: Treatment sequence DE, Part 2: Treatment sequence ED |
Primary outcome
Part 1: Area under the plasma concentration-time curve (AUC) from time zero to the last quantifiable time point (AUC[0-t]) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: AUC from time zero extrapolated to infinite time (AUC[0-infinity]) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: Maximum observed plasma concentration (Cmax)
Time frame: Predose (Day 1) until 72 hour post dose
8 secondary outcomes
Part 1: Time to Cmax (Tmax) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: Elimination half-life (T1/2) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: Concentration at 12 hours post-dose of temsavir
Time frame: 12 hours post-dose
Part 1 and Part 2: Number of participants with clinically significant change from Baseline in vital signs and clinical laboratory parameters
Time frame: Baseline (Day -1) until end of follow up at 4 weeks
Part 1 and Part 2: Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline (Day -1) until end of follow up at 4 weeks
Part 2: AUC [0-t] of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 2: AUC [0-infinity] of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 2: Cmax of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
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 22 Sep 2021.
- Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.
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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
ViiV Healthcare
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 Fostemsavir 600 mg and Fostemsavir 200 mg in people with HIV Infections, run by ViiV Healthcare at 1 site in United States.
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 7 inclusion and 20 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 22 Sep 2021. 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 United States. 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?
Part 1: Area under the plasma concentration-time curve (AUC) from time zero to the last quantifiable time point (AUC[0-t]) of temsavir (time frame: Predose (Day 1) until 72 hour post dose). 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?
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 22 Sep 2021; AzTrials last refreshed its copy on 27 Oct 2026.