Phase 1 Completed N=8 Randomized Double-blind Treatment

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

Pulmonary Disease, Chronic Obstructive

Source: ClinicalTrials.gov NCT03235726 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2019

Primary outcomePrimary: Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106 — 0; 0; 0; 0 Participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Part 1 Cohort A: Number of Participants With Non-serious Adverse Events (NSAEs) and Serious Adverse Events (SAEs) in CCI15106	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1 Cohort B: Number of Participants With NSAEs and SAEs in CCI15106	6; 0; 0; 0	—
PRIMARY Part 1 Cohort C: Number of Participants With NSAEs and SAEs in Bystanders	6; 0	—
PRIMARY Part 2 Cohort A: Number of Participants With NSAEs and SAEs	0; 0; 0; 0	—
PRIMARY Part 2 Cohort B: Number of Participants With NSAEs and SAEs	7; 0	—
PRIMARY Part 1: Number of Participants With Hematology Values of Potential Clinical Importance (PCI) in CCI15106	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1: Number of Participants With Hematology Values of PCI in Bystanders	0; 0; 0; 0; 0; 0	—
PRIMARY Part 2: Number of Participants With Hematology Values of PCI	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1: Number of Participants With Clinical Chemistry Values of PCI in CCI15106	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1: Number of Participants With Clinical Chemistry Values of PCI in Bystanders	0; 0; 0; 0; 0; 0	—
PRIMARY Part 2: Number of Participants With Clinical Chemistry Values of PCI	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1 Cohort A: Potential of Hydrogen (pH) Value by Visit- CCI15106 60 mg SD	6.00; 6.33	—
PRIMARY Part 1 Cohort A: pH Value by Visit- CCI15106 120 mg SD	6.58	—
PRIMARY Part 1 Cohort A: pH Value by Visit- CCI15106 30 mg BID	6.50; 6.92	—
PRIMARY Part 1 Cohort B: pH Value by Visit- CCI15106 60 mg BID	6.21; 6.63; 6.21	—
PRIMARY Part 1: pH Value by Visit- Placebo	6.50; 5.50; 6.25; 7.00; 5.75; 5.50	—
PRIMARY Part 1 Cohort C: pH Value by Visit- CCI15106 in Bystanders	6.36; 6.36; 5.96	—
PRIMARY Part 2 Cohort A: pH Value by Visit- CCI15106	6.25; 6.75; 6.58; 6.50	—
PRIMARY Part 2 Cohort B: pH Value by Visit- CCI15106 60 mg BID	6.13; 5.94; 5.81	—
PRIMARY Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 60 mg SD	1.0217; 1.0105	—
PRIMARY Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 120 mg SD	1.0182	—
PRIMARY Part 1 Cohort A: Specific Gravity Value by Visit- CCI15106 30 mg BID	1.0115; 1.0115	—
PRIMARY Part 1 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID	1.0136; 1.0152; 1.0167	—
PRIMARY Part 1: Specific Gravity Value by Visit- Placebo	1.0148; 1.0150; 1.0150; 1.0150; 1.0120; 1.0150	—
PRIMARY Part 1 Cohort C: Specific Gravity Value by Visit- CCI15106 in Bystanders	1.0191; 1.0163; 1.0182	—
PRIMARY Part 2 Cohort A: Specific Gravity Value by Visit- CCI15106	1.0205; 1.0175; 1.0147; 1.0275	—
PRIMARY Part 2 Cohort B: Specific Gravity Value by Visit- CCI15106 60 mg BID	1.0106; 1.0114; 1.0133	—
PRIMARY Part 1: Number of Participants With Worst Case Post-Baseline 12-lead Electrocardiogram (ECG) of PCI in CCI15106	0; 0; 0; 0; 0; 6	—
PRIMARY Part 1: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI in Bystander	0; 14; 0; 0; 13; 1	—
PRIMARY Part 2: Number of Participants With Worst Case Post-Baseline 12-lead ECG of PCI	1; 0; 0; 5; 2; 8	—
PRIMARY Part 1: Number of Participants With Abnormal Telemetry Findings	0; 0; 0; 0; 0; 0	—
PRIMARY Part 2: Number of Participants With Abnormal Telemetry Findings	0; 0; 0; 0; 0; 1	—
PRIMARY Part 1: Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) at Indicated Time Points	101.0; 101.1; 102.0; 101.5; 99.0; 104.3	—
PRIMARY Part 1: Percent Predicted Forced Vital Capacity (FVC) at Indicated Time Points	101.2; 104.1; 102.0; 101.5; 102.0; 108.3	—
PRIMARY Part 2: Percent Predicted FEV1 at Indicated Time Points	50.3; 51.5; 52.4; 45.3; 41.0; 44.8	—
PRIMARY Part 2: Percent Predicted FVC at Indicated Time Points	74.5; 89.0; 82.8; 72.5; 70.5; 76.6	—
PRIMARY Part 1: Number of Participants With Vital Signs Values of PCI	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1: Number of Participants With Vital Signs Values of PCI in Bystanders	1; 0; 1; 0; 0; 0	—
PRIMARY Part 2: Number of Participants With Vital Signs Values of PCI	0; 0; 0; 0; 0; 0	—
PRIMARY Part 1 Cohort A: Area Under the Curve (AUC) From Time Zero to the Time of Last Quantifiable Concentration (AUC[0-t]) After Single Dose Administration of CCI15106 60 mg on Day 1	1255.3711	—
PRIMARY Part 1 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 120 mg on Day 3	3256.6746	—
PRIMARY Part 2 Cohort A: AUC(0-t) After Single Dose Administration of CCI15106 60 mg on Day 1	862.7642	—
PRIMARY Part 1 Cohort A: Maximum Observed Plasma Concentration (Cmax) After Single Dose Administration of CCI15106 60 mg on Day 1	232.2	—
PRIMARY Part 1 Cohort A: Cmax After Single Dose Administration of CCI15106 120 mg on Day 3	507.6	—
PRIMARY Part 2 Cohort A: Cmax After Single Dose Administration of CCI15106 60 mg on Day 1	179.3	—
PRIMARY Part 1 Cohort A: Time of Maximum Concentration (Tmax) After Single Dose Administration of CCI15106 60 mg on Day 1	0.500	—
PRIMARY Part 1 Cohort A: Tmax After Single Dose Administration of CCI15106 120 mg on Day 3	0.625	—
PRIMARY Part 2 Cohort A: Tmax After Single Dose Administration of CCI15106 60 mg on Day 1	0.500	—
PRIMARY Part 1 Cohort A: AUC From Time Zero to Infinity (AUC[0-infinity]) After Single Dose Administration of CCI15106 60 mg on Day 1	1618.4216	—
PRIMARY Part 1 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 120 mg on Day 3	4418.9437	—
PRIMARY Part 2 Cohort A: AUC(0-infinity) After Single Dose Administration of CCI15106 60 mg on Day 1	968.8838	—
PRIMARY Part 1 Cohort A: Elimination Half-life (t1/2) After Single Dose Administration of CCI15106 60 mg on Day 1	25.8346	—
PRIMARY Part 1 Cohort A: t1/2 After Single Dose Administration of CCI15106 120 mg on Day 3	41.2596	—
PRIMARY Part 2 Cohort A: t1/2 After Single Dose Administration of CCI15106 60 mg on Day 1	16.4000	—
PRIMARY Part 1 Cohort A: Clearance (CL/F) After Single Dose Administration of CCI15106 60 mg on Day 1	37.0732	—
PRIMARY Part 1 Cohort A: CL/F After Single Dose Administration of CCI15106 120 mg on Day 3	27.1558	—
PRIMARY Part 2 Cohort A: CL/F After Single Dose Administration of CCI15106 60 mg on Day 1	61.9269	—
PRIMARY Part 1 Cohort A: AUC From Time Zero to End of Dosing Interval (AUC[0-tau]) After Repeated Dose Administration of CCI15106 30 mg	NA; 1214.2671	—
PRIMARY Part 1 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg	564.7314; 2059.8983	—
PRIMARY Part 2 Cohort B: AUC(0-tau) After Repeated Dose Administration of CCI15106 60 mg	687.0875; 3086.5172	—
PRIMARY Part 1 Cohort A: Cmax After Repeated Dose Administration of CCI15106 30 mg	143.1; 193.9	—
PRIMARY Part 1 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg	188.7; 285.0	—
PRIMARY Part 2 Cohort B: Cmax After Repeated Dose Administration of CCI15106 60 mg	178.2; 423.0	—
PRIMARY Part 1 Cohort A: Tmax After Repeated Dose Administration of CCI15106 30 mg	0.500; 0.500	—
PRIMARY Part 1 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg	0.633; 0.500	—
PRIMARY Part 2 Cohort B: Tmax After Repeated Dose Administration of CCI15106 60 mg	0.633; 0.500	—
PRIMARY Part 1 Cohort A: t1/2 After Repeated Dose Administration of CCI15106 30 mg	NA; 18.1484	—
PRIMARY Part 1 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg	8.3719; 23.0497	—
PRIMARY Part 2 Cohort B: t1/2 After Repeated Dose Administration of CCI15106 60 mg	8.1572; 21.5034	—
PRIMARY Part 1: Concentration of CCI15106 in Plasma of Bystanders: Cohort C	NA	—
PRIMARY Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Bystander: Cohort C	0.53; 0.39; 1.81; 8.99; 1.10; 0.10	—
PRIMARY Part 1: Concentration of CCI15106 Accumulated on Filters Fitted on Stationary Pumps: Cohort C	0.79; 0.50; 2.09; 4.12; 5.80; 0.50	—
SECONDARY Part 1: Concentration of CCI15106 in Lung Epithelial Lining Fluid (ELF) in Repeated Dose of Cohort B 60 mg	47306.383	—
SECONDARY Part 2: Concentration of CCI15106 in ELF in Repeated Dose of Cohort B 60 mg	247290.327	—
SECONDARY Part 1: Number of Participants With Medical Device Incidents in CCI15106	0; 0; 0; 0; 0	—

Eligibility Criteria

Some important 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.

Some Important 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03235726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.