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Healthy Volunteers Bioavailability StudyPhase 1NCT05207111

Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution

A Phase 1 study testing Revefenacin Inhalation Solution in people with Healthy Volunteers Bioavailability Study, run by Mylan Pharma UK Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers Bioavailability Study
What is being tested?
Revefenacin Inhalation Solution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
23 Sep 2021to 30 Sep 2021
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 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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).
  • Negative urine drug screen including at a minimum amphetamines, benzodiazepines, cannabinoid, cocaine, and opiates.
  • Negative Rapid Plasma Reagin (RPR, syphilis test) or Venereal Disease Research laboratory (VDRL) test. Tests for other sexually transmitted diseases (STD).
  • Subjects should be judged by the Principal Investigator or Medical Sub- Investigator as normal and healthy during a pre-study medical evaluation performed within 14 days of the initial dose of study medication

Who cannot join

  • 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.
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  • 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
  • History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychological, genitourinary, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator
  • History of tuberculosis.
  • History of pulmonary problems, such as but not limited to asthma, bronchospasms, and COPD.
  • Acute illness at the time of either the pre-study medical evaluation or dosing.
  • History of glaucoma.
  • History of urinary retention.
  • History of bladder neck obstruction
  • History of symptomatic benign prostatic hyperplasia
  • History of chronic constipation
  • History of long QT syndrome or Subject has an abnormal ECG at Screening or Day -1, including QT interval corrected for heart rate (HR) using Fridericia's formula (QTcF) >470 milliseconds (msec) (applicable for any screening or baseline ECG), or subject has any cardiac rhythm other than sinus rhythm that is interpreted by the investigator to be clinically significant. All ECGs must be not clinically significant to qualify for enrollment into the study.
  • Any reason which, in the opinion of the Principal Investigator or Medical Sub- Investigator would prevent the subject from safely participating in the study.
  • Intolerance to venipuncture.
  • Donation or loss of blood or plasma: 50 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication.
  • Subjects who have received an investigational drug within 90 days prior to the initial dose of study medication.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • Allergy or hypersensitivity to Revefenacin, other related products, or any inactive ingredients

Trial locations and contacts

1 site in 1 country.

China1 site

  • Xuzhou Central Hospital

    Xuzhou

Other trials in China

About this study

Official title: Single-Dose Fasting Bioavailability Study of Mylan's Revefenacin Inhalation Solution, 175 mcg/3 mL in Healthy Chinese Adult Male and Female Volunteers

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.

Read the detailed description

A single-dose, open-labeled, one-period, one-treatment study to investigate the bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL following administration of a single, nebulized, inhaled 175 mcg (1 x 175 mcg/3mL) dose in a total of 24 healthy, Chinese, adult male and female volunteers under fasting conditions. In addition, this study will evaluate the safety and tolerability of Revefenacin Inhalation Solution in the Chinese population. Ten milliliter (1 × 10 mL) blood samples will be collected at pre-dose and the following times after the initiation of dosing: 5, 10, 15, 30, and 45 minutes along with 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours.

The bioavailability of Revefenacin Inhalation Solution, 175 mcg/3 mL will be assessed through various pharmacokinetic parameters (such as AUC0-t, AUC0-∞, Cmax, and Tmax) derived from the plasma concentration-time curves of revefenacin and its active metabolite, THRX-195518.

Being tested
Revefenacin Inhalation Solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Revefenacin Inhalation SolutionDrug

    Also called Yupelri

    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.

Study groups in NCT05207111
Study groupRoleWhat they receive
Revefenacin Inhalation Solution, 175 mcg/3 mLExperimentalNot described
Receives: Drug: Revefenacin Inhalation Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bioavailability

    The maximum concentration (CPEAK)

    Measured: 0 to 96 hours post-dose

  2. Bioavailability

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

    Measured: 0 to 96 hours post-dose

  3. Bioavailability

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

    Measured: 0 to 96 hours post-dose

  4. Bioavailability

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

    Measured: 0 to 96 hours post-dose

  5. Bioavailability

    The elimination rate constant (KEL)

    Measured: 0 to 96 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jan 2022
  2. Study start23 Sep 2021
  3. Primary completion30 Sep 2021
  4. Study completion30 Sep 2021

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05207111
Sponsor's protocol ID
REVE-1-19142
Status last verified
Mar 2022
First submitted
15 Sep 2021
Last updated
4 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Revefenacin Inhalation Solution in people with Healthy Volunteers Bioavailability Study, run by Mylan Pharma UK Ltd. at 1 site in China.

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 18 inclusion and 31 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 4 Apr 2022. 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 China. 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?

Bioavailability (time frame: 0 to 96 hours post-dose). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05207111.

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 4 Apr 2022.

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