Trial Comparing the Safety and Efficacy of Two Different Oral VPV Doses With Placebo as Treatment for RV in Participants With COPD

Purpose

Compare the safety and efficacy of two different oral vapendavir doses with placebo in order to determine the appropriate dose of vapendavir to reduce the severity and/or duration of respiratory symptoms associated with RV infections in patients with COPD.

Condition

  • Rhinovirus Infection

Eligibility

Eligible Ages
Between 40 Years and 85 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

to be assessed only at Randomization: If on stable COPD maintenance therapy this should be stable for at least 2 months prior to randomization. Changes allowed with Sponsor approval (i.e., change within same class due to financial considerations and clinically stable). Clinically stable with no other exacerbations or respiratory infections (viral or bacterial) within 2 months prior to randomization. The presence of RV (without a co-infection) at the time of randomization based on an approved molecular diagnostic test. To be randomized, participants must have at least 3 E-RS scores completed within the previous 35 days to establish a PSB. Exclusion Pregnant or nursing or expected to become pregnant during the study period. Experiencing a current/active or prior exacerbation within 2 months of the Screening Visit (these participants should be rescreened after the exacerbation has been resolved for two months). Participants with other primary causes of chronic airflow limitation: - Including but not limited to: asthma alone (COPD with asthmatic features is acceptable), CF, bronchiolitis obliterans, fibrosis such as TB, IPF, non-CF bronchiectasis with multi-lobe involvement or other major respiratory diagnosis (e.g., allergic bronchopulmonary aspergillosis), etc. Any disorder, for example, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric impairment that is not medically stable, or other major physical impairment that is not considered by the investigator medically stable/controlled. Participants with hepatitis B are excluded. Participants on a stable treatment for HIV can be permitted with permission from the medical monitor. Participants with hepatitis C should be treated and confirmed HCV RNA negative prior to enrollment. (Testing performed at the Screening Visit). In the Investigator's opinion, the participant has any clinically significant laboratory abnormality including an abnormality that indicates clinically significant hematologic, hepatobiliary, or renal disease. Presence of clinically significant out-of-range cardiac interval on the screening ECG including a QTcF > 450 msec (men) and a QTcF > 460 msec (women). Medications or other non-medicinal products that could be impacted by CYP3A4, CYP2C8, or CYP2C19 induction and have serious complications for the participant within the treatment period. Medications that are potent CYP2C8, CYP3A4 or CYP2C19 inducers that would reduce exposures of VPV. Medications that are potent CYP2C8, CYP3A4, or CYP2C19 inhibitors that would increase exposures of VPV. Medications that are substrates of MATE1, OAT3, P-gp, and BCRP for which elevated concentrations are associated with serious and/or life-threatening reactions. Use of either of the following treatments: - Chronic oral/systemic steroids >10 mg per day (inhaled corticosteroids are permitted). - Continuous oxygen via nasal cannula of >2 L/min at the time of Screening or during the Asymptomatic Phase. (Participants on continuous oxygen may have the rate increased during physical exercise/ exertion or to cover any situationally induced decompensation, so long as the participant will resume a continuous rate of ≤2 L/min thereafter). Participation in another investigational drug study within 5 half-lives prior to Screening and during the study is prohibited. This includes approved drugs being evaluated for a new indication. Observational studies are permitted. Participants who have taken VPV in another clinical trial.

Exclusion Criteria

to be assessed only at Randomization: It is already determined, based on the Investigator's clinical judgement, that the participant will likely need antibiotics and/or oral steroids at the Day 1 Randomization Visit. On or within 7 days prior to randomization, there is another active diagnosed infection with viral or bacterial pathogens (i.e., urinary tract infection, cellulitis, etc.) that requires treatment.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dosing Group 1 VPV 1000 mg
The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 1,000 mg VPV will be taken at home the following morning with food. The subsequent 1,000 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
  • Drug: VPV 1000 mg
    Vapendavir 1000 mg
    Other names:
    • Vapendavir
Experimental
Dosing Group 2 VPV 500 mg
The first dose of 1,000 mg VPV will be taken at the study site with food once the Day 1 visit is completed. The second dose of 500 mg VPV will be taken at home the following morning with food. The subsequent 500 mg doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses.
  • Drug: VPV 1000 mg
    Vapendavir 1000 mg
    Other names:
    • Vapendavir
  • Drug: VPV 500 mg
    Vapendavir 500 mg
    Other names:
    • Vapendaivr
Placebo Comparator
Dosing Group 3 Placebo
The first dose of placebo will be taken at the study site with food once the Day 1 visit is completed. The second dose of placebo will be taken at home the following morning with food. The subsequent placebo doses will be taken every 24 hours with food from the time of the second dose for a total of 7 doses
  • Other: Placebo
    Placebo

Recruiting Locations

Velocity Clinical Research - Mobile
Mobile, Alabama 36608
Contact:
Velocity Clinical Research - Mobile

AMR Clinical - Tempe
Tempe, Arizona 85281
Contact:
AMR Clinical - Tempe

310 Clinical Research, LLC
Inglewood, California 90301
Contact:
310 Clinical Research, LLC

NewportNativeMD, Inc.
Newport Beach, California 92663
Contact:
NewportNativeMD, Inc.

Apex Clinical Research
San Diego, California 92120
Contact:
Apex Clinical Research

Synergy Health
Bradenton, Florida 34209
Contact:
Synergy Health

VM Clintrials
Miami Lakes, Florida 33014
Contact:
VM Clintrials

Medquest Translational Sciences
Miami Lakes, Florida 33016
Contact:
Medquest Translational Sciences

Metropolitan Clinical Research Center
Tamarac, Florida 33321
Contact:
Metropolitan Clinical Research Center

Covenant Critical Pulmonary Care
East Point, Georgia 30344
Contact:
Covenant Critical Pulmonary Care

Accelerated Clinical Trials, LLC
Snellville, Georgia 30078
Contact:
Accelerated Clinical Trials, LLC

Bioluminux Clinical Research Illinois
Naperville, Illinois 60540
Contact:
Bioluminux Clinical Research Illinois

Velocity Clinical Research - Valparaiso
Valparaiso, Indiana 46383
Contact:
Velocity Clinical Research - Valparaiso

AMR Clinical - Lexington
Lexington, Kentucky 40509
Contact:
AMR Clinical - Lexington

Patient First Clinical Trials (PFCTRIALS)
Lutherville, Maryland 21093
Contact:
Patient First Clinical Trials (PFCTRIALS)

Verexa Health
Dearborn, Michigan 48126
Contact:
Verexa Health

Oakland Medical Research
Troy, Michigan 48085
Contact:
Oakland Medical Research

Bioluminux Clinical Research New Jersey
Hamilton, New Jersey 08690
Contact:
Bioluminux Clinical Research New Jersey

Velocity Clinical Research - Binghamton
Binghamton, New York 13905
Contact:
Velocity Clinical Research - Binghamton

Brooklyn Clinical Research
Brooklyn, New York 11226
Contact:
Brooklyn Clinical Research

CRC Kings Mountain
Kings Mountain, North Carolina 28086
Contact:
CRC Kings Mountain

Remington-Davis, Inc.
Columbus, Ohio 43215
Contact:
Remington-Davis, Inc.

Hometown Urgent Care - Milford
Milford, Ohio 45150
Contact:
Hometown Urgent Care - Milford

Tekton Research
Edmond, Oklahoma 73013
Contact:
Tekton Research

Velocity Clinical Research - Medford
Medford, Oregon 97504
Contact:
Velocity Clinical Research - Medford

Clinical Research Associates of Central PA, LLC
DuBois, Pennsylvania 15801
Contact:
Clinical Research Associates of Central PA, LLC l

Preferred Primary Care Physicians - St. Clair
Pittsburgh, Pennsylvania 15423
Contact:
Preferred Primary Care Physicians - St. Clair

Velocity Clinical Research - Anderson
Anderson, South Carolina 29621
Contact:
Velocity Clinical Research - Anderson

Clinical Research of Rock Hill
Rock Hill, South Carolina 29732
Contact:
Clinical Research of Rock Hill

Velocity Clinical Research - Spartanburg
Spartanburg, South Carolina 29303
Contact:
Velocity Clinical Research - Spartanburg

Velocity Clinical Research - Union
Union, South Carolina 29379
Contact:
Velocity Clinical Research - Union

Zenos Clinical Research, LLC
Dallas, Texas 75230
Contact:
Zenos Clinical Research, LLC

Activian Clinical Research
Kingwood, Texas 77339
Contact:
Activian Clinical Research

Epic Clinical Research, LLC
Lewisville, Texas 75057
Contact:
Epic Clinical Research, LLC

More Details

Status
Recruiting
Sponsor
Altesa Biosciences, Inc.

Study Contact

Karen Fusaro
610-242-0903
kfusaro@altesa.com