HealthyPhase 1NCT03443453
A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers
A Phase 1 study testing MIV-711 in people with Healthy, run by Medivir at 1 site in United States.
Trial summary
This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers Read more about this study
- Who is it for?
- Ages 19 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- MIV-711
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2018to 17 Feb 2018
- 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 19 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- If not a menopausal female or surgically sterile male or female, subjects must be willing to practice at least one of the in the CSP described highly effective methods of birth control for at least a (partner's) menstrual cycle before and for 3 months after study drug administration.
- For a female of non-childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to the first dose:
- hysteroscopic sterilization;
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- bilateral tubal ligation or bilateral salpingectomy;
- hysterectomy;
- bilateral oophorectomy; or be postmenopausal with amenorrhea for at least 2 years prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status as per PI or designee judgment.
Who cannot join
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, that could affect the action, absorption, or disposition of MIV-711 or may confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of known structural cardiac abnormalities, syncope, cardiac conduction problems (first, second, or third degree heart blocks, bundle branch block, or incomplete block, atrial fibrillation and/or paroxysmal atrial fibrillation, sick sinus syndrome or prolonged QTc interval), inappropriate sinus bradycardia, deviant ECG morphology or exercise related cardiac events.
- Unable to refrain from or anticipates the use of:
- Any drug, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dose and throughout the study. Medication listed as part of acceptable birth control methods will be allowed.
- Any drugs known to be inducers of CYP enzymes for 28 days prior to the first dose of study drug and throughout the study. Appropriate sources will be consulted by the PI or designee to confirm lack of PK/PD interaction with study drug.
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- Acetaminophen (up to 2 g per 24 hour period) may be permitted during the study.
- Hormone replacement therapy will also be allowed.
- Subjects on a stable dose (at least 3 months) of thyroid medication will be allowed.
- An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics Following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers
This is a single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers
- Conditions
- Healthy
- Being tested
- MIV-711
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIV-711Drug
MIV-711 administered as tablets and capsules at four occasions
| Study group | Role | What they receive |
|---|---|---|
| MIV-711 ABCD | Experimental | Subjects will first receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B). Thereafter they will receive the capsule formulation under fasted conditions (C) followed by the capsule formulation administered under fed conditions (D). Receives: Drug: MIV-711 |
| MIV-711 CDAB | Experimental | Subjects will first receive the capsule formulation under fasted conditions (C)followed by the capsule formulation administered under fed conditions (D). Thereafter they will receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B). Receives: Drug: MIV-711 |
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 0 to the last observed non-zero concentration (t) (AUC0-t)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Measured: 0 to 72 hours post dose
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Measured: 0 to 72 hours post dose
Maximum observed concentration (Cmax)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Measured: 0 to 72 hours post dose
Time to reach maximum observed concentration (Tmax)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Measured: 0 to 72 hours post dose
Apparent terminal elimination rate constant (Kel)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Measured: 0 to 72 hours post dose
Apparent terminal elimination half-life (T½)
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Measured: 0 to 72 hours post dose
Secondary outcomes (4)
The number and severity of AEs/SAE
Safety and tolerability of MIV-711 measured by number and severity of AEs/SAEs
Measured: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant abnormal lab results
Safety and tolerability of MIV-711 measured by number of clinical significant abnormal lab results.
Measured: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant ECG abnormalities
Safety and tolerability of MIV-711 measured by number of clinical significant ECG abnormalities.
Measured: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant physical examination abnormalities
Safety and tolerability of MIV-711 measured by number of clinical significant physical examination abnormalities.
Measured: from study start until 7+/-2 days after the last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start19 Jan 2018
- Primary completion17 Feb 2018
- Study completion17 Feb 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivir
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Allen Hunt, Principal investigator, Celerion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443453
- Sponsor's protocol ID
- MIV-711-102
- Status last verified
- Feb 2018
- First submitted
- 22 Jan 2018
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics Following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03443453
- Acronym / sponsor ID
- MIV-711-102
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MedivirIndustry (pharma, biotech, devices)
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 17 Feb 2018 (actual)
- Study completion
- 17 Feb 2018 (actual)
- First posted
- 23 Feb 2018 (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 single-Center, Randomised, 4-Period, Phase 1 Study to Evaluate the Pharmacokinetics, Safety and Tolerability, and Effect of Food on Pharmacokinetics following Single Doses of MIV-711 Capsule and Tablet Formulations in Healthy Volunteers
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIV-711 ABCD | Experimental | Drug: MIV-711Subjects will first receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B). Thereafter they will receive the capsule formulation under fasted conditions (C) followed by the capsule formulation administered under fed conditions (D). |
| MIV-711 CDAB | Experimental | Drug: MIV-711Subjects will first receive the capsule formulation under fasted conditions (C)followed by the capsule formulation administered under fed conditions (D). Thereafter they will receive the tablet formulation under fasted conditions (A) followed by the tablet formulation administered under fed conditions (B). |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy, adult, male or female, 19-55 years of age, inclusive, at screening.
- Body mass index (BMI) ≥ 18.5 and ≤ 30.0 kg/m2 at screening.
- Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs, as deemed by the PI or designee.
- If not a menopausal female or surgically sterile male or female, subjects must be willing to practice at least one of the in the CSP described highly effective methods of birth control for at least a (partner's) menstrual cycle before and for 3 months after study drug administration.
- For a female of non-childbearing potential: must have undergone one of the following sterilization procedures at least 6 months prior to the first dose:
Key exclusion criteria (10 listed)
- History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.
- History of any illness that, in the opinion of the PI or designee, that could affect the action, absorption, or disposition of MIV-711 or may confound the results of the study or poses an additional risk to the subject by their participation in the study.
- History or presence of known structural cardiac abnormalities, syncope, cardiac conduction problems (first, second, or third degree heart blocks, bundle branch block, or incomplete block, atrial fibrillation and/or paroxysmal atrial fibrillation, sick sinus syndrome or prolonged QTc interval), inappropriate sinus bradycardia, deviant ECG morphology or exercise related cardiac events.
- Unable to refrain from or anticipates the use of:
- An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.
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 |
|---|---|---|
| MIV-711MIV-711 administered as tablets and capsules at four occasions | Drug | MIV-711 ABCD, MIV-711 CDAB |
Primary outcome
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t)
Time frame: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf)
Time frame: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Maximum observed concentration (Cmax)
Time frame: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Time to reach maximum observed concentration (Tmax)
Time frame: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Apparent terminal elimination rate constant (Kel)
Time frame: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
Apparent terminal elimination half-life (T½)
Time frame: 0 to 72 hours post dose
The PK of MIV-711 following administration of single oral doses of capsule and tablet formulations under fasting and fed conditions in healthy subjects. The evaluation will be made between the formulations.
4 secondary outcomes
The number and severity of AEs/SAE
Time frame: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant abnormal lab results
Time frame: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant ECG abnormalities
Time frame: from study start until 7+/-2 days after the last study drug administration
The number of clinically significant physical examination abnormalities
Time frame: from study start until 7+/-2 days after the last study drug administration
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 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
Allen Hunt principal investigator
Celerion
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 MIV-711 in people with Healthy, run by Medivir 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 9 inclusion and 10 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 23 Feb 2018. 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?
Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t) (time frame: 0 to 72 hours post dose). The study lists 6 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 23 Feb 2018.