Refractory Chronic CoughPhase 1NCT05628740

Placebo-controlled, Single and Multiple Dose Study in Healthy Volunteers and Refractory Chronic Cough Patients to Assess the Safety, Tolerability, and Pharmacokinetics of Two Formulations of NTX-1175

A Phase 1 study testing 3 mg NOC-100 (via nebulizer), 1 mg NOC-110 (via DPI) [1x 1 mg capsule] and 3 mg NOC-110 (via DPI) in people with Refractory Chronic Cough, run by Nocion Therapeutics at 3 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

Part 1 will evaluate the safety, tolerability and PK of single doses of three dose levels of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) compared to a single dose reference nebulizer (NOC-100) treatment in healthy participants. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Refractory Chronic Cough
What is being tested?: 3 mg NOC-100 (via nebulizer), 1 mg NOC-110 (via DPI) [1x 1 mg capsule] and 3 mg NOC-110 (via DPI)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 3 sitesUnited States
Study dates: 7 Feb 2022to 25 Oct 2022
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 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Participants must meet all of the following criteria to be eligible for participation in the study:
Male or female participants between the ages of 18 to 65 years, inclusive, at the time of screening (Part 1) and between the ages of 18 to 85 years, inclusive, at the time of screening (Part 2).
Has had rCC diagnosis for ≥ 12 months (Part 2) prior to screening.
Awake-cough frequency of ≥20 per hour (average) at Screening (Part 2).
Score of ≥40 mm on the Cough Severity Visual Analog Scale (VAS) at Screening (Part 2).
Chest radiograph or CT thorax within the last 60 months not demonstrating any abnormality considered to be significantly contributing to the rCC. (Part 2)

Show all 12Show fewer

Body mass index (BMI) ≥19.0 and ≤32.0 kg/m2, inclusive, at Screening.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2 x upper limit of normal (ULN); alkaline phosphatase (ALP) and bilirubin ≤1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Creatinine clearance ≥50 mL/min.
Must be fully SARS-CoV-2 vaccinated.
Must be SARS-CoV-2 negative via rapid antigen testing or polymerase chain reaction (PCR) test at Screening and PCR at Check-in Day -1.
In the Investigator's opinion, has no clinically significant disease and/or clinically significant abnormal laboratory values as determined by the Investigator based on medical history, physical examination, or laboratory evaluations conducted at the screening visit or on admission to the clinical research unit.

Who cannot join

Participants who meet any one of the following criteria will be deemed ineligible for participation in the study:
Is found to have positive test for SARS-CoV-2 at Screening or Check-in Day -1, whether or not this was accompanied by the clinical symptoms of COVID-19.
Current smoker or individuals who have given up smoking within the past 6 months prior to screening, or those with >20 pack-year smoking history (Part 2)
Current diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, unexplained pulmonary fibrosis, or asthma (Part 2).
History or presence of alcohol or drug use disorder, per Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), within the past 2 years prior to screening.
Current opiate/opioid use in the past 7 days prior to screening, or medical history of opiate/opioid use disorder.

Show all 23Show fewer

Unable to refrain from the use of:
Gabapentin, pregabalin, and/or amitryptline or other tricyclics within 4 weeks prior to screening and throughout the study (Part 2)
Chronic, systemic corticosteroid use within 4 weeks prior to screening and throughout the study (Part 2).
Inhalers including long-acting and short acting beta 2-agonists (LABA and SABA), and inhaled corticosteroids (ICS) within 8 weeks prior to screening and throughout the study.
Lidocaine or related compounds of any form within 14 days prior to screening and throughout the study (Part 2).
Medication or remedies to aid sleeping 14 days prior to screening and throughout the study (Part 2).
Angiotensin-converting enzyme (ACE)-inhibitor within 12 weeks prior to screening and throughout the study (Part 2).
Antitussives 7 days prior to screening and throughout the study (Part 2).
Speech and language therapy for rCC within 4 weeks prior to screening and throughout the study (Part 2).
Food and beverages containing alcohol for 24 hours prior to screening (Part 2).
History or presence of cardiac dysfunction including arrhythmia, bundle branch block; Wolff Parkinson White syndrome, recent thromboembolic event, prolonged PR (≥220 msec), QRS (≥120 msec), QTcF interval (≥450 msec [males] or ≥470 msec [females]) or has ECG findings deemed abnormal with clinical significance by the Investigator or designee at Screening.
Positive results at Screening for HIV, HBsAg, or HCV (participants successfully treated for HCV may be permitted at the discretion of the Investigator).
Supine blood pressure is less than 90/40 mmHg or greater than 140/90 mmHg (Part 1), or greater than 160/95 mmHg (Part 2) at Screening. Vital signs may be repeated twice.
Supine heart rate is lower than 40 beats per minute (bpm) or higher than 99 bpm at Screening. Vital signs may be repeated twice.
History of asthma or COPD (Part 1).
Forced expiratory volume in 1 second/ forced vital capacity (FEV1/FVC) < lower limit of normal (LLN) per Global Lung Health Initiative normative dataset at Screening.
Had symptoms of any significant acute illness, including symptoms of COVID-19 within 30 days before the start of the study (time of first dose), as determined by the Investigator.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Clinical Site Partners
Leesburg, Florida, 32789
Celerion
Phoenix, Arizona, 85283
Clinical Site Partners
Winter Park, Florida, 34748

Other trials in United States

About this study

Official title: A Phase 1, Two Part, Placebo-controlled, Single Dose Study in Healthy Volunteers and Multiple Dose Study in Patients With Refractory Chronic Cough to Assess the Safety, Tolerability, and PK of NTX-1175 Administered Via Nebulizer (NOC-100) and Dry Powder Inhaler (NOC-110)

Part 2 will evaluate the safety, tolerability and PK of multiple doses of NTX-1175 drug substance administered by dry powder inhaler (NOC-110) to participants with refractory chronic cough. Part 2 will also evaluate the treatment effect of multiple doses of one dose level of NTX-1175 drug substance administered by dry powder inhaler (NOC-110).

Read the detailed description

Part 1 is a randomized, double-blinded 3 period crossover and 1 period parallel study of single dose administration of NOC-110 via dry powder inhaler, preceded by a reference period of NOC-100 administered via nebulizer. A total of 12 healthy participants will be enrolled to ensure that 9 participants complete this part of study.

Part 2 is a randomized, double-blinded, placebo-controlled, multiple-dose, parallel design study in patients with refractory chronic cough. A total of 12 participants will be enrolled to ensure that 8 participants complete this part of study.

Conditions: Refractory Chronic Cough
Being tested: 3 mg NOC-100 (via nebulizer), 1 mg NOC-110 (via DPI) [1x 1 mg capsule], 3 mg NOC-110 (via DPI), Placebo (via DPI), 6 mg NOC-110 (via DPI)
Medical subject headings: Chronic Cough

What participants receive

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

3 mg NOC-100 (via nebulizer)Drug
Participants determined to be eligible for Part 1 of the study will be enrolled and will be assigned to receive a single dose of the reference nebulizer treatment of NOC 100 at 3 mg (Treatment A) in Period 1
1 mg NOC-110 (via DPI) [1x 1 mg capsule]Drug
Participants will be randomized to receive single doses of 1 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule
3 mg NOC-110 (via DPI)Drug
Participants will be randomized to receive single doses of 3 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule
Placebo (via DPI)Drug
Participants will be randomized to receive single doses of placebo via capsule in a crossover fashion according to a prespecified randomization schedule
6 mg NOC-110 (via DPI)Drug
Participants will be randomized to receive single doses of 6 mg NOC-110 via DPI in a parallel fashion according to a prespecified randomization schedule
Placebo (via DPI) [2x Placebo capsules]Drug
Participants will be randomized to receive single doses of Placebo (via DPI) [2x Placebo capsules] in a parallel fashion according to a prespecified randomization schedule

Study groups in NCT05628740
Study group	Role	What they receive
Part 1-Period 1-Treatment A	Experimental	3 mg NOC-100 (via nebulizer) Receives: Drug: 3 mg NOC-100 (via nebulizer)
Part 1-Periods 2 through 4 -Treatment B	Placebo comparator	1 mg NOC-110 DPI (1 capsule) Receives: Drug: 1 mg NOC-110 (via DPI) [1x 1 mg capsule]
Part 1-Periods 2 through 4 - Treatment C	Placebo comparator	3mg NOC-110 DPI (1 capsule) Receives: Drug: 3 mg NOC-110 (via DPI)
Part 1-Periods 2 through 4- Placebo	Placebo comparator	Placebo (1 capsule) Receives: Drug: Placebo (via DPI)
Part 1-Period 5- Treatment D	Placebo comparator	6mg NOC-110 DPI (2 capsules) Receives: Drug: 6 mg NOC-110 (via DPI)
Part 1-Period 5- Placebo	Placebo comparator	Placebo (2 capsules) Receives: Drug: Placebo (via DPI) [2x Placebo capsules]
Part 2- Active	Placebo comparator	6mg NOC-110 DPI (2 capsules) Receives: Drug: 6 mg NOC-110 (via DPI)
Part 2- Placebo	Placebo comparator	Placebo DPI (2 capsules) Receives: Drug: Placebo (via DPI) [2x Placebo capsules]

What is being measured

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

Number and severity of Treatment Emergent Adverse Events (TEAEs) following single doses of NOC-110 or placebo administered with a DPI
To evaluate the safety and tolerability of single doses of three dose levels of NTX-1175 drug substance administered by DPI (Drug Product NOC-110) compared to a single dose reference nebulizer treatment (Drug Product NOC-100) in healthy participants, number and severity of TEAEs following single doses of NOC-110 or placebo administered with a DPI compared to a reference period administration of NOC 100 via a nebulizer in healthy adult participants will be reported.
Measured: Part 1- Screening through Day 23
Number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough.
To evaluate the safety and tolerability of multiple doses of NOC-110 administered by DPI to participants with refractory chronic cough (rCC), number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough will be reported.
Measured: Part 2- Screening through Day 12

Secondary outcomes (18)

Peak plasma concentration (Cmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175:
Cmax
Measured: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The time to reach maximum observed concentration (Tmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175:
Tmax
Measured: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The area under the concentration-time (AUC) curve of single doses of three dose levels of NOC-110 compared to a single dose reference nebulizer treatment in healthy participants.
PK parameters for plasma NTX-1175:
AUC [time 0 to the last observed non-zero concentration (t) (AUC0-t), time 0 to Hour 24 (AUC0-24), time 0 extrapolated to infinity (AUC0-inf), percent of AUC0 inf extrapolated (AUC%extrap)]
Measured: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The time of the last measurable concentration (Tlast) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175:
Tlast
Measured: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The apparent terminal elimination half-life (t½) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175:
t½
Measured: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The apparent terminal elimination rate constant (Kel) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
PK parameters for plasma NTX-1175:
Kel
Measured: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The Cmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
Cmax and maximum observed concentration at steady-state (Cmax, ss)
Measured: Part 2- Day 1, Day 5
The Tmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
Tmax, time to reach Cmax,ss (Tmax,ss)
Measured: Part 2- Day 1, Day 5
The AUC of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
AUC0-t AUC0-inf AUC%extrap
Measured: Part 2- Day 1, Day 5
The Tlast of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
Tlast
Measured: Part 2- Day 1, Day 5
The t½ of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
t½
Measured: Part 2- Day 1, Day 5
The Kel multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
Kel
Measured: Part 2- Day 1, Day 5
The concentration observed at the end of the dosing interval (Ctrough) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
Ctrough
Measured: Part 2- Days 2 to 4
The minimum observed non zero concentration between dose time and dose time + dosing interval (tau) (min,ss,) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
Cmin,ss
Measured: Part 2- Day 5
The area under the concentration-time curve during a dosing interval (tau), at steady state (AUCtau) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
AUCtau
Measured: Part 2- Day 5
The average concentration during a dosing interval, at steady state (Cavg,ss) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
Cavg,ss
Measured: Part 2- Day 5
The accumulation (R) of multiple doses of NOC 110 administered by DPI to participants with rCC.
PK parameters for plasma NTX-1175:
R
Measured: Part 2- Day 5
Awake-coughs per hour in participants with rCC
The treatment effect of multiple doses of one dose level of NOC-110 administered by DPI, as determined by awake-coughs per hour in participants with rCC.
Measured: Part 2- Screening, Day -1, Day 1, Day 3 and Day 5

Timeline

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

7 Feb 202225 Oct 2022

First posted29 Nov 2022
Study start7 Feb 2022
Primary completion25 Oct 2022
Study completion25 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Refractory Chronic CoughStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Randomised
Intervention model: Sequential
Model description: Part 1: randomized, double-blind, placebo-controlled, 3-period crossover, and 1-period parallel study. Part 2: randomized, double-blind, placebo-controlled, multiple-dose, parallel-design.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05628740
Sponsor's protocol ID: NOC110-C-102
Status last verified: Nov 2022
First submitted: 2 Nov 2022
Last updated: 30 Mar 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Refractory Chronic Cough trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Two Part, Placebo-controlled, Single Dose Study in Healthy Volunteers and Multiple Dose Study in Patients With Refractory Chronic Cough to Assess the Safety, Tolerability, and PK of NTX-1175 Administered Via Nebulizer (NOC-100) and Dry Powder Inhaler (NOC-110)
ClinicalTrials.gov ID: NCT05628740
Acronym / sponsor ID: NOC110-C-102
Conditions: Refractory Chronic Cough
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Nocion TherapeuticsIndustry (pharma, biotech, devices)
Study start: 7 Feb 2022 (actual)
Primary completion: 25 Oct 2022 (actual)
Study completion: 25 Oct 2022 (actual)
First posted: 29 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 8
Model description: Part 1: randomized, double-blind, placebo-controlled, 3-period crossover, and 1-period parallel study. Part 2: randomized, double-blind, placebo-controlled, multiple-dose, parallel-design.

Arm	Type	Receives
Part 1-Period 1-Treatment A	Experimental	Drug: 3 mg NOC-100 (via nebulizer)3 mg NOC-100 (via nebulizer)
Part 1-Periods 2 through 4 -Treatment B	Placebo comparator	Drug: 1 mg NOC-110 (via DPI) [1x 1 mg capsule]1 mg NOC-110 DPI (1 capsule)
Part 1-Periods 2 through 4 - Treatment C	Placebo comparator	Drug: 3 mg NOC-110 (via DPI)3mg NOC-110 DPI (1 capsule)
Part 1-Periods 2 through 4- Placebo	Placebo comparator	Drug: Placebo (via DPI)Placebo (1 capsule)
Part 1-Period 5- Treatment D	Placebo comparator	Drug: 6 mg NOC-110 (via DPI)6mg NOC-110 DPI (2 capsules)
Part 1-Period 5- Placebo	Placebo comparator	Drug: Placebo (via DPI) [2x Placebo capsules]Placebo (2 capsules)
Part 2- Active	Placebo comparator	Drug: 6 mg NOC-110 (via DPI)6mg NOC-110 DPI (2 capsules)
Part 2- Placebo	Placebo comparator	Drug: Placebo (via DPI) [2x Placebo capsules]Placebo DPI (2 capsules)

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Participants must meet all of the following criteria to be eligible for participation in the study:
Male or female participants between the ages of 18 to 65 years, inclusive, at the time of screening (Part 1) and between the ages of 18 to 85 years, inclusive, at the time of screening (Part 2).
Has had rCC diagnosis for ≥ 12 months (Part 2) prior to screening.
Awake-cough frequency of ≥20 per hour (average) at Screening (Part 2).
Score of ≥40 mm on the Cough Severity Visual Analog Scale (VAS) at Screening (Part 2).

Key exclusion criteria (23 listed)

Participants who meet any one of the following criteria will be deemed ineligible for participation in the study:
Is found to have positive test for SARS-CoV-2 at Screening or Check-in Day -1, whether or not this was accompanied by the clinical symptoms of COVID-19.
Current smoker or individuals who have given up smoking within the past 6 months prior to screening, or those with >20 pack-year smoking history (Part 2)
Current diagnosis of chronic obstructive pulmonary disease (COPD), bronchiectasis, unexplained pulmonary fibrosis, or asthma (Part 2).
History or presence of alcohol or drug use disorder, per Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), within the past 2 years prior to screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3 mg NOC-100 (via nebulizer)Participants determined to be eligible for Part 1 of the study will be enrolled and will be assigned to receive a single dose of the reference nebulizer treatment of NOC 100 at 3 mg (Treatment A) in Period 1	Drug	Part 1-Period 1-Treatment A
1 mg NOC-110 (via DPI) [1x 1 mg capsule]Participants will be randomized to receive single doses of 1 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule	Drug	Part 1-Periods 2 through 4 -Treatment B
3 mg NOC-110 (via DPI)Participants will be randomized to receive single doses of 3 mg NOC-110 (via DPI) in a crossover fashion according to a prespecified randomization schedule	Drug	Part 1-Periods 2 through 4 - Treatment C
Placebo (via DPI)Participants will be randomized to receive single doses of placebo via capsule in a crossover fashion according to a prespecified randomization schedule	Drug	Part 1-Periods 2 through 4- Placebo
6 mg NOC-110 (via DPI)Participants will be randomized to receive single doses of 6 mg NOC-110 via DPI in a parallel fashion according to a prespecified randomization schedule	Drug	Part 1-Period 5- Treatment D, Part 2- Active
Placebo (via DPI) [2x Placebo capsules]Participants will be randomized to receive single doses of Placebo (via DPI) [2x Placebo capsules] in a parallel fashion according to a prespecified randomization schedule	Drug	Part 1-Period 5- Placebo, Part 2- Placebo

Primary outcome

Number and severity of Treatment Emergent Adverse Events (TEAEs) following single doses of NOC-110 or placebo administered with a DPI
Time frame: Part 1- Screening through Day 23
To evaluate the safety and tolerability of single doses of three dose levels of NTX-1175 drug substance administered by DPI (Drug Product NOC-110) compared to a single dose reference nebulizer treatment (Drug Product NOC-100) in healthy participants, number and severity of TEAEs following single doses of NOC-110 or placebo administered with a DPI compared to a reference period administration of NOC 100 via a nebulizer in healthy adult participants will be reported.
Number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough.
Time frame: Part 2- Screening through Day 12
To evaluate the safety and tolerability of multiple doses of NOC-110 administered by DPI to participants with refractory chronic cough (rCC), number and severity of TEAE following repeat doses of NOC 110 compared to placebo in participants with chronic cough will be reported.

18 secondary outcomes

Peak plasma concentration (Cmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Time frame: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The time to reach maximum observed concentration (Tmax) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Time frame: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The area under the concentration-time (AUC) curve of single doses of three dose levels of NOC-110 compared to a single dose reference nebulizer treatment in healthy participants.
Time frame: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The time of the last measurable concentration (Tlast) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Time frame: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The apparent terminal elimination half-life (t½) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Time frame: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The apparent terminal elimination rate constant (Kel) of single doses of three dose levels of NOC-110 administered by DPI compared to a single dose reference nebulizer treatment (NOC-100) in healthy participants.
Time frame: Part 1- Day 1, Day 5, Day 9, Day 13 and Day 17
The Cmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 1, Day 5
The Tmax of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 1, Day 5
The AUC of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 1, Day 5
The Tlast of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 1, Day 5
The t½ of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 1, Day 5
The Kel multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 1, Day 5
The concentration observed at the end of the dosing interval (Ctrough) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Days 2 to 4
The minimum observed non zero concentration between dose time and dose time + dosing interval (tau) (min,ss,) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 5
The area under the concentration-time curve during a dosing interval (tau), at steady state (AUCtau) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 5
The average concentration during a dosing interval, at steady state (Cavg,ss) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 5
The accumulation (R) of multiple doses of NOC 110 administered by DPI to participants with rCC.
Time frame: Part 2- Day 5
Awake-coughs per hour in participants with rCC
Time frame: Part 2- Screening, Day -1, Day 1, Day 3 and Day 5

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christopher Silber, MD study director

Nocion Therapeutics, Inc.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 12 inclusion and 23 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 30 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. 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?

Number and severity of Treatment Emergent Adverse Events (TEAEs) following single doses of NOC-110 or placebo administered with a DPI (time frame: Part 1- Screening through Day 23). The study lists 2 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 NCT05628740.

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 30 Mar 2023.