Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution

NCT05207111 | Completed Phase 1

• 1 other identifier: REVE-1-19142
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

Single-Dose Fasting Bioavailability Study of Revefenacin Inhalation Solution, 175 mcg/3 mL in 24 Healthy Chinese Adult Male and Female Volunteers. This study will evaluate the safety and tolerability of Revefenacin Inhalation Solution in the Chinese population. For the determination of the pharmacokinetic disposition of the formulations, The bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL will be assessed through various pharmacokinetic parameters derived from the plasma concentration-time curves of revefenacin and its active metabolite, THRX-195518.

Conditions

Healthy Volunteers Bioavailability Study

Outcome Measures

Primary Outcomes (5)

• Bioavailability

  The maximum concentration (CPEAK)

  0 to 96 hours post-dose

• Bioavailability

  The Area under the plasma concentration-time curve (AUCL)

  0 to 96 hours post-dose

• Bioavailability

  The time at which it occurred relative to the administered dose (TPEAK)

  0 to 96 hours post-dose

• Bioavailability

  Area under the plasma concentration-time curve from zero to infinity (AUCINF)

  0 to 96 hours post-dose

• Bioavailability

  The elimination rate constant (KEL)

  0 to 96 hours post-dose

Study Arms (1)

Revefenacin Inhalation Solution, 175 mcg/3 mL

EXPERIMENTAL

Drug: Revefenacin Inhalation Solution

Interventions

Revefenacin Inhalation Solution DRUG

Revefenacin Inhalation Solution, 175 mcg/3 mL following a single nebulized inhaled 175 mcg (1 x 175 mcg/3 mL) dose administered under fasting conditions.

Also known as: Yupelri

Revefenacin Inhalation Solution, 175 mcg/3 mL

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of written informed consent
• Healthy male and female volunteers aged 18 to 55
• Males and/or non-pregnant, non-lactating females.
• Women will not be considered of childbearing potential if one of the following is reported and documented on the medical history:
• Postmenopausal with spontaneous amenorrhea for at least one (1) year, or spontaneous amenorrhea for less than one (1) year with serum FSH levels \>40mIU/ml as confirmed by lab test at screening, or
• Bilateral oophorectomy with or without a hysterectomy and an absence of bleeding for at least 6 months, or
• Total hysterectomy and an absence of bleeding for at least 3 months.
• Women of childbearing potential will need to have a negative serum β-HCG pregnancy test performed within 14 days prior to the start of the study.
• Weight at least 50 kg (110 lbs) for men and 45 kg (99 lbs) for women and have a Body Mass Index (BMI) value less than or equal to 26.0 kg/m2 but greater than or equal to 19.0 kg/m2.
• Smoking Status: Non-nicotine users only.
• Adequate venous access in both arms for the collection of a number of blood samples during the study.
• Utilization of illiterate subjects is permitted when performed according to GCP, as well as regulations/guidance for the region of submission and country of conductance.
• Willing to follow the protocol requirements and comply with protocol restrictions.
• Negative chest X-ray for tuberculosis may be performed (within 6 months of study and documentation available) at the discretion of the Principal Investigator or Medical Sub Investigator.
• Normal spirometry assessment (FEV1 ≥ 80% predicted and FEV1/FVC ≥ 0.7).

You may not qualify if:

• Institutionalized subjects.
• Social Habits
• Ingestion of any alcoholic beverage within the 48 hours prior to the initial administration of study medication.
• Ingestion of any caffeine- or xanthine-containing food or beverage within the 24 hours prior to the initial administration of study medication.
• Ingestion of any vitamins or herbal products within 7 days prior to the initial administration of the study medication.
• Any recent, significant change in dietary or exercise habits.
• History of drug and/or alcohol abuse within one year of start of study.
• Use of any nicotine containing product(s) within 1 year of the initial dose of study medication.
• Medications
• Use of any prescription or over-the-counter (OTC) medications within the 14 days prior to the initial administration of study medication.
• Use of any hormone replacement therapy within 3 months prior to initial administration of study medication.
• A depot injection or implant of any drug within 3 months prior to initial administration of study medication.
• Use of any medication, herbal supplement, or vitamin known to induce or inhibit hepatic enzyme activity or transporters within 28 days prior to the initial administration of study medication. (see https://go.usa.gov/xXY9C).
• Use of any food (e.g. broccoli, Brussels sprouts, char-grilled meat, star fruit, pomegranate, seville oranges grapefruit, grapefruit-like, or grapefruit containing products) known to induce or inhibit hepatic enzyme activity must be limited to no more than 2 standard servings (e.g. one standard serving of char-grilled meat is approximately 12 ounces; one standard serving of vegetables/fruits is approximately 1 cup) per week within 4 weeks prior to the initial dose of study medication. These foods must be discontinued at least 7 days prior to the initial dose of study medication, during the study and until the end of the study.
• Diseases

Sponsors & Collaborators

• Mylan Pharma UK Ltd.: lead

Study Sites (1)

Xuzhou Central Hospital

Xuzhou, China

Location

MeSH Terms

Interventions

revefenacin

Study Officials

• Andrew Shaw, PhD

  Head of Global PKDM Science Oversight

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: January 26, 2022
• Study Start: September 23, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 4, 2022

Record last verified: 2022-03

Locations

CN (1)