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

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ClinicalTrials.gov Identifier: NCT03443453
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Medivir

Brief 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

Condition or disease Intervention/treatment Phase
Healthy Drug: MIV-711 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : January 19, 2018
Actual Primary Completion Date : February 17, 2018
Actual Study Completion Date : February 17, 2018

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443453


Locations
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United States, Nebraska
Celerion
Lincoln, Nebraska, United States, 68502
Sponsors and Collaborators
Medivir
Investigators
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Principal Investigator: Allen Hunt Celerion

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Responsible Party: Medivir
ClinicalTrials.gov Identifier: NCT03443453     History of Changes
Other Study ID Numbers: MIV-711-102
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No