A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes

Sponsor
Fontem US LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04430634
Collaborator
Fontem Ventures BV (Industry)
40
Enrollment
1
Location
8
Arms
3
Actual Duration (Months)
13.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers.

Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Myblu variant A
  • Other: Myblu variant B
  • Other: Myblu variant C
  • Other: Myblu variant D
  • Other: Myblu variant E
  • Other: Myblu variant F
  • Other: Myblu variant G
  • Other: Myblu variant H
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers
Actual Study Start Date :
Nov 1, 2019
Actual Primary Completion Date :
Jan 31, 2020
Actual Study Completion Date :
Jan 31, 2020

Arms and Interventions

ArmIntervention/Treatment
Experimental: ABDC

Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).

Other: Myblu variant A
Use of Myblu e-cigarette with flavor A 2.4% nicotine

Other: Myblu variant B
Use of Myblu e-cigarette with flavor B 3.6% nicotine

Other: Myblu variant C
Use of Myblu e-cigarette with flavor C 2.5% nicotine

Other: Myblu variant D
Use of Myblu e-cigarette with flavor D 4.0% nicotine

Experimental: BCAD

Same as previous arm, but in a different randomization order.

Other: Myblu variant A
Use of Myblu e-cigarette with flavor A 2.4% nicotine

Other: Myblu variant B
Use of Myblu e-cigarette with flavor B 3.6% nicotine

Other: Myblu variant C
Use of Myblu e-cigarette with flavor C 2.5% nicotine

Other: Myblu variant D
Use of Myblu e-cigarette with flavor D 4.0% nicotine

Experimental: CDBA

Same as previous arm, but in a different randomization order.

Other: Myblu variant A
Use of Myblu e-cigarette with flavor A 2.4% nicotine

Other: Myblu variant B
Use of Myblu e-cigarette with flavor B 3.6% nicotine

Other: Myblu variant C
Use of Myblu e-cigarette with flavor C 2.5% nicotine

Other: Myblu variant D
Use of Myblu e-cigarette with flavor D 4.0% nicotine

Experimental: DACB

Same as previous arm, but in a different randomization order.

Other: Myblu variant A
Use of Myblu e-cigarette with flavor A 2.4% nicotine

Other: Myblu variant B
Use of Myblu e-cigarette with flavor B 3.6% nicotine

Other: Myblu variant C
Use of Myblu e-cigarette with flavor C 2.5% nicotine

Other: Myblu variant D
Use of Myblu e-cigarette with flavor D 4.0% nicotine

Experimental: EFHG

Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A washout period of 12 hours product abstinence is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).

Other: Myblu variant E
Use of Myblu e-cigarette with flavor E 3.6% nicotine

Other: Myblu variant F
Use of Myblu e-cigarette with flavor F 2.4% nicotine

Other: Myblu variant G
Use of Myblu e-cigarette with flavor G 4.0% nicotine

Other: Myblu variant H
Use of Myblu e-cigarette with flavor H 3.6% nicotine

Experimental: FGEH

Same as previous arm, but in a different randomization order.

Other: Myblu variant E
Use of Myblu e-cigarette with flavor E 3.6% nicotine

Other: Myblu variant F
Use of Myblu e-cigarette with flavor F 2.4% nicotine

Other: Myblu variant G
Use of Myblu e-cigarette with flavor G 4.0% nicotine

Other: Myblu variant H
Use of Myblu e-cigarette with flavor H 3.6% nicotine

Experimental: GHFE

Same as previous arm, but in a different randomization order.

Other: Myblu variant E
Use of Myblu e-cigarette with flavor E 3.6% nicotine

Other: Myblu variant F
Use of Myblu e-cigarette with flavor F 2.4% nicotine

Other: Myblu variant G
Use of Myblu e-cigarette with flavor G 4.0% nicotine

Other: Myblu variant H
Use of Myblu e-cigarette with flavor H 3.6% nicotine

Experimental: HEGF

Same as previous arm, but in a different randomization order.

Other: Myblu variant E
Use of Myblu e-cigarette with flavor E 3.6% nicotine

Other: Myblu variant F
Use of Myblu e-cigarette with flavor F 2.4% nicotine

Other: Myblu variant G
Use of Myblu e-cigarette with flavor G 4.0% nicotine

Other: Myblu variant H
Use of Myblu e-cigarette with flavor H 3.6% nicotine

Outcome Measures

Primary Outcome Measures

  1. Maximum Nicotine Concentration in Blood [180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)]

    Maximum nicotine concentration in blood (Cmax)

  2. Concentration of Carboxyhemoglobin in Blood [Baseline and 8 days]

    Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.

  3. Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours [Baseline and 8 days]

    Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).

  4. Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours [Baseline and 8 days]

    Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).

  5. Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours [Baseline and 8 days]

    Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).

Secondary Outcome Measures

  1. Level of White Blood Cells [Baseline and 8 days]

    The change from baseline in the level of white blood cells, a biomarker of potential harm.

  2. Spirometry: Forced Expiratory Volume in 1 Second [Baseline and 8 days]

    Forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.

  3. Spirometry: Forced Vital Capacity [Baseline and 8 days]

    Forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.

  4. Subjective Measure: Urge to Smoke [8 days]

    Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale (VAS). The scale ranges from "Not at all", given a score of 0, to "Extremely", given a score of 100, after ad libitum use of the product.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening

  • tested positive for urine cotinine (≥ 200 ng/mL) at Screening

  • exhaled carbon monoxide > 10 ppm (parts per million) at Screening

Exclusion Criteria:
  • relevant illness history

  • relevant medication use

  • body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening

  • allergy to propylene glycol or glycerin

  • use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in

  • use of any prescription smoking cessation treatments within 3 months prior to Check-in

  • smokers who draw smoke from the cigarette into the mouth and throat but do not inhale

  • planning to quit smoking during the study

  • female subjects who are pregnant, lactating, or intend to become pregnant

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1CelerionLincolnNebraskaUnited States68502

Sponsors and Collaborators

  • Fontem US LLC
  • Fontem Ventures BV

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Fontem US LLC
ClinicalTrials.gov Identifier:
NCT04430634
Other Study ID Numbers:
  • CA22749
First Posted:
Jun 12, 2020
Last Update Posted:
Jun 7, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group TitleABDCBCADCDBADACBEFHGFGEHGHFEHEGF
Arm/Group DescriptionSubjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).Same as previous but in a different randomization orderSame as previous but in a different randomization orderSame as previous but in a different randomization orderSubjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).Same as previous but in a different randomization orderSame as previous but in a different randomization orderSame as previous but in a different randomization order
Period Title: Overall Study
STARTED55555555
COMPLETED55545545
NOT COMPLETED00010010

Baseline Characteristics

Arm/Group TitleABDCBCADCDBADACBEFHGFGEHGHFEHEGFTotal
Arm/Group DescriptionSubjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).Same as previous but in a different randomization orderSame as previous but in a different randomization orderSame as previous but in a different randomization orderSubjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days. A 12-hour washout period is observed between product variants. For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).Same as previous but in a different randomization orderSame as previous but in a different randomization orderSame as previous but in a different randomization orderTotal of all reporting groups
Overall Participants5555555540
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
46.0
(15.28)
38.6
(14.03)
47.6
(8.73)
37.8
(10.76)
44.6
(10.88)
41.6
(11.19)
43.0
(11.51)
47.2
(12.58)
43.3
(11.45)
Sex: Female, Male (Count of Participants)
Female
3
60%
2
40%
2
40%
1
20%
2
40%
1
20%
1
20%
4
80%
16
40%
Male
2
40%
3
60%
3
60%
4
80%
3
60%
4
80%
4
80%
1
20%
24
60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
0
0%
0
0%
0
0%
1
20%
0
0%
0
0%
0
0%
0
0%
1
2.5%
Not Hispanic or Latino
5
100%
5
100%
5
100%
4
80%
5
100%
5
100%
5
100%
5
100%
39
97.5%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]
25.8
(4.5)
29.3
(2.1)
29.4
(5.5)
29.2
(4.3)
26.4
(7.3)
25.3
(3.3)
28.2
(3.7)
27.5
(3.3)
27.6
(4.4)

Outcome Measures

1. Primary Outcome
TitleMaximum Nicotine Concentration in Blood
DescriptionMaximum nicotine concentration in blood (Cmax)
Time Frame180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleProduct Variant AProduct Variant BProduct Variant CProduct Variant DProduct Variant EProduct Variant FProduct Variant GProduct Variant H
Arm/Group DescriptionMyBlu e-cigarette variant A (2.4% nicotine)MyBlu e-cigarette variant B (3.6% nicotine)MyBlu e-cigarette variant C (2.5% nicotine)MyBlu e-cigarette variant D (4.0% nicotine)MyBlu e-cigarette variant E (3.6% nicotine)MyBlu e-cigarette variant F (2.4% nicotine)MyBlu e-cigarette variant G (4.0% nicotine)MyBlu e-cigarette variant H (3.6% nicotine)
Measure Participants1918191818191918
Geometric Mean (Geometric Coefficient of Variation) [ng/mL]
3.6
(91.6)
5.3
(109.6)
4.0
(113.5)
5.3
(106.4)
6.5
(135.7)
4.6
(143.4)
8.0
(99.6)
9.3
(95.8)
2. Primary Outcome
TitleConcentration of Carboxyhemoglobin in Blood
DescriptionChange from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
Time FrameBaseline and 8 days

Outcome Measure Data

Analysis Population Description
The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.
Arm/Group TitleExclusive MyBlu E-cigarette Use
Arm/Group DescriptionSubjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants39
Baseline value
7.7
(2.1)
Change from baseline
-6.25
(2.06)
3. Primary Outcome
TitleAmount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours
DescriptionChange from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).
Time FrameBaseline and 8 days

Outcome Measure Data

Analysis Population Description
The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.
Arm/Group TitleExclusive MyBlu E-cigarette Use
Arm/Group DescriptionSubjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants39
Baseline value
345.4
(252.3)
Change from baseline
-262.8
(205.1)
4. Primary Outcome
TitleAmount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours
DescriptionChange from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).
Time FrameBaseline and 8 days

Outcome Measure Data

Analysis Population Description
The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.
Arm/Group TitleExclusive MyBlu E-cigarette Use
Arm/Group DescriptionSubjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants39
Baseline value
1242.2
(536.0)
Change from baseline
-1097.1
(522.2)
5. Primary Outcome
TitleAmount of S-phenyl Mercapturic Acid in Urine in 24 Hours
DescriptionChange from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).
Time FrameBaseline and 8 days

Outcome Measure Data

Analysis Population Description
The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.
Arm/Group TitleExclusive MyBlu E-cigarette Use
Arm/Group DescriptionSubjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants39
Baseline value
5.9
(4.2)
Change from baseline
-5.9
(4.1)
6. Secondary Outcome
TitleLevel of White Blood Cells
DescriptionThe change from baseline in the level of white blood cells, a biomarker of potential harm.
Time FrameBaseline and 8 days

Outcome Measure Data

Analysis Population Description
The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.
Arm/Group TitleExclusive MyBlu E-cigarette Use
Arm/Group DescriptionSubjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants39
Baseline value
7.5
(1.7)
Change from baseline
-0.4
(1.1)
7. Secondary Outcome
TitleSpirometry: Forced Expiratory Volume in 1 Second
DescriptionForced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.
Time FrameBaseline and 8 days

Outcome Measure Data

Analysis Population Description
The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.
Arm/Group TitleExclusive MyBlu E-cigarette Use
Arm/Group DescriptionSubjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants38
Baseline value
2.9
(1.2)
8 days timepoint
3.2
(0.9)
8. Secondary Outcome
TitleSpirometry: Forced Vital Capacity
DescriptionForced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.
Time FrameBaseline and 8 days

Outcome Measure Data

Analysis Population Description
The arms are combined into one group, because the aim was to compare biomarkers in all participants who use any e-cigarette variant, to the value at baseline (when they were smoking conventional cigarettes). Data is missing for 2 participants at the 8 days timepoint.
Arm/Group TitleExclusive MyBlu E-cigarette Use
Arm/Group DescriptionSubjects who used any MyBlu e-cigarette variant for 8 days (all subjects who completed Part 1 of the study)
Measure Participants38
Baseline value
3.8
(1.5)
8 days timepoint
4.2
(1.2)
9. Secondary Outcome
TitleSubjective Measure: Urge to Smoke
DescriptionUrge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale (VAS). The scale ranges from "Not at all", given a score of 0, to "Extremely", given a score of 100, after ad libitum use of the product.
Time Frame8 days

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group TitleProduct Variant AProduct Variant BProduct Variant CProduct Variant DProduct Variant EProduct Variant FProduct Variant GProduct Variant H
Arm/Group DescriptionMyBlu e-cigarette variant A (2.4% nicotine)MyBlu e-cigarette variant B (3.6% nicotine)MyBlu e-cigarette variant C (2.5% nicotine)MyBlu e-cigarette variant D (4.0% nicotine)MyBlu e-cigarette variant E (3.6% nicotine)MyBlu e-cigarette variant F (2.4% nicotine)MyBlu e-cigarette variant G (4.0% nicotine)MyBlu e-cigarette variant H (3.6% nicotine)
Measure Participants1919191919192019
Mean (Standard Deviation) [score on a scale]
70.4
(18.7)
67.8
(24.8)
67.2
(21.7)
63.7
(22.1)
62.0
(31.6)
56.2
(34.4)
62.9
(32.1)
63.0
(29.4)

Adverse Events

Time Frame9 days
Adverse Event Reporting Description
Arm/Group TitleProduct Variant AProduct Variant BProduct Variant CProduct Variant DProduct Variant EProduct Variant FProduct Variant GProduct Variant H
Arm/Group DescriptionMyBlu e-cigarette variant A (2.4% nicotine)MyBlu e-cigarette variant B (3.6% nicotine)MyBlu e-cigarette variant C (2.5% nicotine)MyBlu e-cigarette variant D (4.0% nicotine)MyBlu e-cigarette variant E (3.6% nicotine)MyBlu e-cigarette variant F (2.4% nicotine)MyBlu e-cigarette variant G (4.0% nicotine)MyBlu e-cigarette variant H (3.6% nicotine)
All Cause Mortality
Product Variant AProduct Variant BProduct Variant CProduct Variant DProduct Variant EProduct Variant FProduct Variant GProduct Variant H
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Serious Adverse Events
Product Variant AProduct Variant BProduct Variant CProduct Variant DProduct Variant EProduct Variant FProduct Variant GProduct Variant H
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Other (Not Including Serious) Adverse Events
Product Variant AProduct Variant BProduct Variant CProduct Variant DProduct Variant EProduct Variant FProduct Variant GProduct Variant H
Affected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# EventsAffected / at Risk (%)# Events
Total1/19 (5.3%) 4/19 (21.1%) 3/19 (15.8%) 2/20 (10%) 3/19 (15.8%) 2/19 (10.5%) 0/20 (0%) 3/20 (15%)
Eye disorders
Abnormal sensation in eye0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 1/20 (5%)
Eyelid irritation0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 1/20 (5%)
Eyelid pain0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 1/20 (5%)
Swelling of eyelid0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 1/20 (5%)
Gastrointestinal disorders
Constipation1/19 (5.3%) 1/19 (5.3%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Flatulence0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 1/19 (5.3%) 0/20 (0%) 0/20 (0%)
General disorders
Feeling hot0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 1/19 (5.3%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Musculoskeletal and connective tissue disorders
Back pain0/19 (0%) 1/19 (5.3%) 1/19 (5.3%) 0/20 (0%) 1/19 (5.3%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Pain in extremity0/19 (0%) 0/19 (0%) 0/19 (0%) 1/20 (5%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Nervous system disorders
Dizziness0/19 (0%) 2/19 (10.5%) 0/19 (0%) 0/20 (0%) 1/19 (5.3%) 1/19 (5.3%) 0/20 (0%) 1/20 (5%)
Headache0/19 (0%) 0/19 (0%) 1/19 (5.3%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Psychiatric disorders
Nervousness0/19 (0%) 0/19 (0%) 0/19 (0%) 1/20 (5%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Respiratory, thoracic and mediastinal disorders
Dysphonia0/19 (0%) 0/19 (0%) 1/19 (5.3%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Throat tightness0/19 (0%) 0/19 (0%) 1/19 (5.3%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Skin and subcutaneous tissue disorders
Acne0/19 (0%) 1/19 (5.3%) 0/19 (0%) 0/20 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 0/20 (0%)
Blister0/19 (0%) 0/19 (0%) 0/19 (0%) 0/20 (0%) 1/19 (5.3%) 0/19 (0%) 0/20 (0%) 0/20 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitlePaul Morris
OrganizationNerudia
Phone+44 7508 708 917
Emailpaul.morris@nerudia.com
Responsible Party:
Fontem US LLC
ClinicalTrials.gov Identifier:
NCT04430634
Other Study ID Numbers:
  • CA22749
First Posted:
Jun 12, 2020
Last Update Posted:
Jun 7, 2021
Last Verified:
May 1, 2021