Clinical trial NCT03443453: A Bioavailability Study of MIV-711 Oral Formulations in Healthy Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Medivir
Sponsor class: INDUSTRY
First posted: 2018-02-23
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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


Eligibility 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.

Primary outcomes:
measure: Area under the concentration-time curve, from time 0 to the last observed non-zero concentration (t) (AUC0-t)
timeFrame: 0 to 72 hours post dose
measure: Area under the concentration-time curve, from time 0 extrapolated to infinity (AUC0-inf)
timeFrame: 0 to 72 hours post dose
measure: Maximum observed concentration (Cmax)
timeFrame: 0 to 72 hours post dose
measure: Time to reach maximum observed concentration (Tmax)
timeFrame: 0 to 72 hours post dose
measure: Apparent terminal elimination rate constant (Kel)
timeFrame: 0 to 72 hours post dose
measure: Apparent terminal elimination half-life (T½)
timeFrame: 0 to 72 hours post dose
Secondary outcomes:
measure: The number and severity of AEs/SAE
timeFrame: from study start until 7+/-2 days after the last study drug administration
measure: The number of clinically significant abnormal lab results
timeFrame: from study start until 7+/-2 days after the last study drug administration
measure: The number of clinically significant ECG abnormalities
timeFrame: from study start until 7+/-2 days after the last study drug administration
measure: The number of clinically significant physical examination abnormalities
timeFrame: from study start until 7+/-2 days after the last study drug administration
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion
state: Nebraska
Study officials:
affiliation: Celerion
name: Allen Hunt
role: PRINCIPAL_INVESTIGATOR
References: