Trial Outcomes & Findings for A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine (NCT NCT03268343)
NCT ID: NCT03268343
Last Updated: 2019-02-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
3 mg Cytisine, Schedule A: Fed Then Fasted
* Period 1: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
* Period 2: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
3 mg Cytisine, Schedule B: Fasted Then Fed
* Period 1: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
* Period 2: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study in Healthy Volunteers to Investigate the Effect of Food on the Bioavailability of Cytisine
Baseline characteristics by cohort
| Measure |
3 mg Cytisine
n=24 Participants
3 mg Cytisine, Schedule A: Fed Then Fasted
* Period 1: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
* Period 2: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
3 mg Cytisine, Schedule B: Fasted Then Fed
* Period 1: Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
* Period 2: Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
|---|---|
|
Age, Continuous
|
35.1 years
STANDARD_DEVIATION 10.25 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other, Not Specified
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)Population: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Plasma Cytisine Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)
|
22.9 ng/mL
Standard Deviation 5.44
|
30.8 ng/mL
Standard Deviation 7.91
|
PRIMARY outcome
Timeframe: Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)Population: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Plasma Cytisine PK: Total Area Under the Curve From Time Zero to Infinity (AUC0-∞)
|
170 h*ng/mL
Standard Deviation 30.3
|
176 h*ng/mL
Standard Deviation 33.1
|
SECONDARY outcome
Timeframe: Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)Population: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Plasma Cytisine PK: Time of Occurrence of Cmax (Tmax)
|
2.75 hours
Interval 0.5 to 6.12
|
0.75 hours
Interval 0.333 to 3.0
|
SECONDARY outcome
Timeframe: Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)Population: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Plasma Cytisine PK: AUC From Time Zero to the Last Sampling Time (AUC0-t)
|
163 h*ng/mL
Standard Deviation 29.4
|
169 h*ng/mL
Standard Deviation 33.0
|
SECONDARY outcome
Timeframe: Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)Population: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Plasma Cytisine PK: Residual Area, or Percentage of Extrapolated Part for the Calculation of AUC0-∞ (AUC%)
|
4.37 percentage of extrapolated part
Standard Deviation 1.40
|
3.85 percentage of extrapolated part
Standard Deviation 1.46
|
SECONDARY outcome
Timeframe: Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)Population: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Plasma Cytisine PK: Apparent Terminal Elimination Rate Constant (Lambda z)
|
0.154 1/hour
Standard Deviation 0.0391
|
0.156 1/hour
Standard Deviation 0.0314
|
SECONDARY outcome
Timeframe: Pre-dose (within 60 minutes of dosing); 15 minutes, 20 minutes, 30 minutes, 45 minutes, 1 hour, 1.5 hours, 2 hours, 2.5 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 14 hours, 16 hours and 24 hours post-dose (+/- 1 minute)Population: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Plasma Cytisine PK: Apparent Terminal Elimination Half-Life (t1/2)
|
4.77 hours
Standard Deviation 1.16
|
4.59 hours
Standard Deviation 0.832
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to first dose); 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours and 12-24 hours post-dosePopulation: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Urine Cytisine PK: Amount Excreted in Urine Over Time (Ae)
|
2.59 mg
Standard Deviation 0.407
|
2.47 mg
Standard Deviation 0.357
|
SECONDARY outcome
Timeframe: Pre-dose (within 30 minutes prior to first dose); 0-2 hours, 2-4 hours, 4-8 hours, 8-12 hours and 12-24 hours post-dosePopulation: PK Set: All participants who received doses under both fed and fasted conditions and did not have an occurrence of vomiting which rendered the concentration profile unreliable. (Two participants were excluded for vomiting before twice the median Tmax had been reached following 3 mg cytisine administered in a fed state.)
To assess the renal elimination of cytisine via measurement of urinary concentrations of cytisine.
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=22 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Urine Cytisine PK: Percentage of Drug Excreted in Urine (Ae%)
|
86.5 percentage of drug excreted
Standard Deviation 13.6
|
82.4 percentage of drug excreted
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Day -1 to Day 7 plus 6-8 days (post-study follow-up)Population: Safety Analysis Set: all participants who received at least one dose of cytisine.
An adverse event (AE) is defined as any untoward medical occurrence which does not necessarily have a causal relationship with the treatment. TEAEs are defined as AEs not present prior to first administration of investigational product, or AEs present before first administration of study drug that worsen after the subject receives the first dose of study drug. A serious adverse event (SAE) is defined as an AE that: results in death; is life-threatening; requires hospitalization or prolongs existing inpatient's hospitalization; results in persistent or significant disability or incapacity; results in a congenital abnormality or birth defect; is an important medical event which requires medical intervention to prevent any of the above outcomes. Event severity was categorized as mild, moderate, or severe. Relationship of event to study drug was categorized as definite, probably, possible, unlikely, not related, or not applicable (N/A).
Outcome measures
| Measure |
3 mg Cytisine, Fed
n=24 Participants
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=24 Participants
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE Possibly Related to Study Drug
|
3 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE Unlikely Related to Study Drug
|
1 participants
|
1 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE Not Related to Study Drug
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE Relationship to Study Drug = N/A
|
1 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE
|
6 participants
|
7 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 Serious TEAE
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE Leading to Withdrawal of Study Drug
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 Mild TEAE
|
6 participants
|
7 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 Moderate TEAE
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 Severe TEAE
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE Definitely Related to Study Drug
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and Relationship
≥ 1 TEAE Probably Related to Study Drug
|
1 participants
|
1 participants
|
Adverse Events
3 mg Cytisine, Fed
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
3 mg Cytisine, Fasted
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
3 mg Cytisine, Overall
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
3 mg Cytisine, Fed
n=24 participants at risk
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
|
3 mg Cytisine, Fasted
n=24 participants at risk
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
3 mg Cytisine, Overall
n=24 participants at risk
Cytisine (2 x 1.5 mg tablets) administered 30 minutes after the start of a high fat breakfast (fed state).
Cytisine (2 x 1.5 mg tablets) administered after an overnight fast of at least 10 hours (fasting state).
|
|---|---|---|---|
|
Surgical and medical procedures
Tooth repair
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Gastrointestinal disorders
Nausea
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
8.3%
2/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
2/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
12.5%
3/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
General disorders
Feeling hot
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Infections and infestations
Rhinitis
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Nervous system disorders
Dizziness
|
8.3%
2/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
12.5%
3/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
16.7%
4/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Nervous system disorders
Headache
|
8.3%
2/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
8.3%
2/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
12.5%
3/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Nervous system disorders
Hypoaesthesia
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
4.2%
1/24 • Day -1 to Day 7 plus 6-8 days (post-study follow-up)
For each reporting group, a participant was counted only once per system organ class and preferred term. Consequently, if the same preferred term was observed for a participant in both fed and fasted states, the participant was counted only once in the "3 mg Cytisine, Overall" reporting group for that preferred term.
|
Additional Information
Daniel Cain, Senior Director Clinical Research
Achieve Life Sciences
Phone: 425.686.1546
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Principal Investigators are bound by requirements outlined in their individual clinical trial agreements with regard to publication of trial results.
- Publication restrictions are in place
Restriction type: OTHER