Study of Safety and Drug Levels of CCI15106 Inhalation Powder in Healthy Adults and Adults With Moderate Chronic Obstructive Pulmonary Disease. Study of CCI15106 Levels in People Standing Near the Person Inhaling the Drug

NCT ID: NCT03235726

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-13
• Study Completion Date: 2018-06-19

Brief Summary

This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Cohort A, Part 1: Active

60 milligrams (mg) single dose of CCI15106 will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered twice daily (BID) on Days 6-19 to healthy subjects.

Group Type: EXPERIMENTAL

CCI15106

Intervention Type: DRUG

One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Cohort A, Part 1: Placebo

60 mg single dose of placebo will be administered by inhalation route on Day 1; 120 mg single dose will be administered on Day 3; and then 30 mg dose will be administered BID on Days 6-19 to healthy subjects.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Cohort B, Part 1: Active

60 mg of CCI15106 BID will be administered by inhalation route for 14 days to healthy subjects.

Group Type: EXPERIMENTAL

CCI15106

Intervention Type: DRUG

One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Cohort B, Part 1: Placebo

60 mg of placebo BID will be administered by inhalation route for 14 days to healthy subjects.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Cohort C, Part 1: bystanders

Healthy subjects will be enrolled to follow bystander exposure and will be studied concomitantly with Cohort B.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Cohort A, Part 2: Active

60 mg single dose of CCI15106 will be administered by inhalation route to subjects with COPD.

Group Type: EXPERIMENTAL

CCI15106

Intervention Type: DRUG

One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Cohort A, Part 2: Placebo

60 mg single dose of placebo will be administered by inhalation route to subjects with COPD.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Cohort B, Part 2: Active

60 mg BID dose of CCI15106 will be administered by inhalation route for 14 days to subjects with COPD.

Group Type: EXPERIMENTAL

CCI15106

Intervention Type: DRUG

One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Cohort B, Part 2: Placebo

60 mg BID dose of placebo will be administered by inhalation route for 14 days to subjects with COPD.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Interventions

CCI15106

One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Intervention Type: DRUG

Placebo

One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

For healthy subjects and bystanders:

• 18 to 65 years of age.
• Healthy as determined by a doctor.
• Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
• Women who are not pregnant or breastfeeding, and not of childbearing potential.

For subjects with COPD:

• 40 to 75 years of age.
• Diagnosed with moderate COPD by a doctor.
• Have breathing test results that are consistent with moderate COPD as defined in the study protocol.
• A smoker or an ex-smoker.
• Men who agree to use contraception during the treatment period and for at least 7 months after the last dose of study medicine and agree not to donate sperm during this period.
• Women who are not pregnant or breastfeeding, and not of childbearing potential.

Exclusion Criteria

For healthy subjects and bystanders:

• History of liver disease.
• Use of over-the-counter or prescription drugs (including vitamins) 7 days before the study until completion of the follow-up visit.
• Participation in the study would result in loss of more than 500 milliliter (mL) of blood within 3 months.
• Participation in another clinical trial with an investigational product within about 3 months before this study.
• Positive drug/alcohol screen.
• Regular use of known drugs of abuse.
• Regular alcohol consumption within 3 months before the study.
• Breath test indicative of smoking at study start.
• Documented lactose allergy/intolerance.
• Men whose partner is pregnant or breastfeeding cannot participate.
• Certain blood test results may not allow subjects to participate, as described in the study protocol.

For subjects with COPD:

• History of liver disease.
• Poorly controlled COPD disease as, for example, more than 2 exacerbations of COPD per year.
• Some respiratory conditions, like for example active tuberculosis, lung cancer or any other respiratory condition. Subjects with other respiratory conditions (for example, clinically significant: asthma, pulmonary fibrosis, bronchiectasis) are excluded if these conditions are the primary cause of their respiratory symptoms.
• Unstable or uncontrolled cardiac disease.
• Problems with kidney function as defined in the study protocol.
• Past or current medical conditions or diseases that are not well controlled.
• Subjects are not allowed to take oral corticosteroids from 4 weeks prior to screening and for the duration of the study.
• Subjects taking medications for any chronic conditions have to be on stable doses for 4 weeks before screening and until after study treatment is finished.
• Use of short-acting inhaled bronchodilators is allowed, but subjects must be able to stop their medications several times during the study.
• Use of long-acting bronchodilators is allowed, but subjects must be able to change the schedule of their medications twice during the study.
• Participation in the study would result in loss of more than 500 mL within 3 months.
• Participation in another clinical trial with an investigational product within about 3 months before this study.
• Positive drug/alcohol screen.
• Regular use of known drugs of abuse.
• Regular alcohol consumption within 3 months before the study.
• Unable to refrain from smoking for certain periods during the study (maximum about 6 hours).
• Documented lactose allergy/intolerance.
• Men whose partner is pregnant or breastfeeding cannot participate.
• Certain blood test results may not allow subjects to participate, as described in the study protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Park Royal, London, United Kingdom

Countries

United Kingdom

References

Dumont EF, Oliver AJ, Ioannou C, Billiard J, Dennison J, van den Berg F, Yang S, Chandrasekaran V, Young GC, Lahiry A, Starbuck DC, Harrell AW, Georgiou A, Hopchet N, Gillies A, Baker SJ. A Novel Inhaled Dry-Powder Formulation of Ribavirin Allows for Efficient Lung Delivery in Healthy Participants and Those with Chronic Obstructive Pulmonary Disease in a Phase 1 Study. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02267-19. doi: 10.1128/AAC.02267-19. Print 2020 Apr 21.

Reference Type: DERIVED

PMID: 32071044 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-001070-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

205822

Identifier Type: -

Identifier Source: org_study_id