A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers

February 21, 2018 updated by: Medivir

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (subset):

  • 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;
    • 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.

Exclusion Criteria (subset):

  • 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.
    • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MIV-711 ABCD
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).
Drug: MIV-711
MIV-711 administered as tablets and capsules at four occasions
Experimental: MIV-711 CDAB
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).
Drug: MIV-711
MIV-711 administered as tablets and capsules at four occasions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
0 to 72 hours post dose
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.
0 to 72 hours post dose
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.
0 to 72 hours post dose
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.
0 to 72 hours post dose
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.
0 to 72 hours post dose
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.
0 to 72 hours post dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number and severity of AEs/SAE
Time Frame: from study start until 7+/-2 days after the last study drug administration
Safety and tolerability of MIV-711 measured by number and severity of AEs/SAEs
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
Safety and tolerability of MIV-711 measured by number of clinical significant abnormal lab results.
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
Safety and tolerability of MIV-711 measured by number of clinical significant ECG abnormalities.
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
Safety and tolerability of MIV-711 measured by number of clinical significant physical examination abnormalities.
from study start until 7+/-2 days after the last study drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medivir

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Allen Hunt, Celerion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MIV-711-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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