Urine Cytisine PK: Amount Excreted in Urine Over Time (Ae)Secondary· 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-dose
Group
Value
95% CI
3 mg Cytisine, Fed
2.59
± 0.407
3 mg Cytisine, Fasted
2.47
± 0.357
Urine Cytisine PK: Percentage of Drug Excreted in Urine (Ae%)Secondary· 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-dose
To assess the renal elimination of cytisine via measurement of urinary concentrations of cytisine.
Group
Value
95% CI
3 mg Cytisine, Fed
86.5
± 13.6
3 mg Cytisine, Fasted
82.4
± 11.9
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, and Discontinuation of Study Drug Due to AEs, by Severity and RelationshipSecondary· Day -1 to Day 7 plus 6-8 days (post-study follow-up)
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; resu
≥ 1 TEAE
Group
Value
95% CI
3 mg Cytisine, Fed
6
3 mg Cytisine, Fasted
7
≥ 1 Serious TEAE
Group
Value
95% CI
3 mg Cytisine, Fed
0
3 mg Cytisine, Fasted
0
≥ 1 TEAE Leading to Withdrawal of Study Drug
Group
Value
95% CI
3 mg Cytisine, Fed
0
3 mg Cytisine, Fasted
0
≥ 1 Mild TEAE
Group
Value
95% CI
3 mg Cytisine, Fed
6
3 mg Cytisine, Fasted
7
≥ 1 Moderate TEAE
Group
Value
95% CI
3 mg Cytisine, Fed
0
3 mg Cytisine, Fasted
0
≥ 1 Severe TEAE
Group
Value
95% CI
3 mg Cytisine, Fed
0
3 mg Cytisine, Fasted
0
≥ 1 TEAE Definitely Related to Study Drug
Group
Value
95% CI
3 mg Cytisine, Fed
0
3 mg Cytisine, Fasted
0
≥ 1 TEAE Probably Related to Study Drug
Group
Value
95% CI
3 mg Cytisine, Fed
1
3 mg Cytisine, Fasted
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Day -1 to Day 7 plus 6-8 days (post-study follow-up).
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This will be an open-label, randomised, 2-period, single-dose crossover study to determine the comparative bioavailability of cytisine following single-dose administration in healthy male and female subjects under fed and fasted conditions.
The study will be comprised of a pre-study screen, followed by 2 treatment periods (1 and 2) and a post-study follow-up.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Other Achieve Life Sciences trials
Trials by the same sponsor.
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· completed
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Sponsor: as reported to ClinicalTrials.gov by Achieve Life Sciences
Last refreshed: 26 February 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03268343.