A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects

Sponsor
Idorsia Pharmaceuticals Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03907215
Collaborator
(none)
24
1
2
2.6
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Study Details

Study Description

Brief Summary

A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Single-center, single-blind, randomized, placebo-controlled, sequential design Phase 1 study with the inclusion of two double-blind nested crossover partsSingle-center, single-blind, randomized, placebo-controlled, sequential design Phase 1 study with the inclusion of two double-blind nested crossover parts
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind to the administration of ACT-541468 (participant). Single- and double-blind to the administration of ACT-541468 (Investigator, single-/double blind is dependent on treatment arm team). Single-blind study with the inclusion of two double-blind nested crossover parts, i.e., subjects will remain blinded to all administrations of ACT-541468.
Primary Purpose:
Other
Official Title:
A Single-center, Single-blind, Randomized, Placebo-controlled, Sequential Design Phase 1 Study With the Inclusion of Two Double-blind Nested Crossover Parts to Investigate the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
Actual Study Start Date :
Apr 9, 2019
Actual Primary Completion Date :
Jun 26, 2019
Actual Study Completion Date :
Jun 26, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Treatment A and B

On Day 1 and Day 2, subjects will EITHER receive: a single dose of 50 mg ACT-541468 (Treatment A) on Day 1 and a single dose of ACT- 541468 placebo (Treatment B) on Day 2 OR a single dose of ACT-541468 placebo (Treatment B) on Day 1 and a single dose of 50 mg ACT-541468 (Treatment A) on Day 2.

Drug: ACT541468
50 mg; film-coated tablet for oral use

Drug: ACT541468 placebo
film-coated tablet for oral use

Other: Treatment C, D, E, and F

From Day 3 to Day 10, subjects will on each day receive: • a single dose of 20 mg citalopram and EITHER a single dose of ACT-541468 placebo OR a single dose of 50 mg ACT-541468.

Drug: ACT541468
50 mg; film-coated tablet for oral use

Drug: ACT541468 placebo
film-coated tablet for oral use

Drug: Citalopram
20 mg; tablet tor oral use; for single- or repeated dosing

Outcome Measures

Primary Outcome Measures

  1. Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation [From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10]

Other Outcome Measures

  1. Number of participants with treatment-emergent AEs from study treatment administration up to EOS [AEs from Day 1 to EOS; for up to 15 days post-dose]

  2. Number of participants with treatment-emergent SAEs from study treatment administration up to EOS [SAEs from Day 1 to EOS; for up to 50 days post-dose]

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Signed informed consent prior to any study-mandated procedure.

  • Healthy male and female subjects aged between 24 and 55 years (inclusive) at Screening.

  • Body mass index of 18.5 to 29.9 kg/m2 (inclusive) at Screening.

  • Women of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day -1. They must consistently and correctly use a highly effective method of contraception, be sexually inactive, or have a vasectomized partner.

  • Women of non-childbearing potential (i.e., postmenopausal, with previous bilateral salpingectomy, bilateral salpingo oophorectomy or hysterectomy, or with premature ovarian failure, XY genotype, Turner syndrome, uterine agenesis).

  • Healthy on the basis of physical examination, cardiovascular assessments, and clinical laboratory tests.

Exclusion Criteria:
  • Pregnant or lactating women.

  • Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

  • Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy.

  • Any contraindication to citalopram or any other selective serotonin reuptake inhibitor.

  • History of cardiovascular disease (e.g., congenital long QT syndrome, arrhythmia).

  • Relevant history of a suicide attempt or suicidal behavior.

  • Personal or family history of psychiatric disorder(s).

  • Individuals of Asian descent.

  • History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to Screening.

  • Excessive caffeine consumption, defined as ≥ 800 mg per day at screening.

  • Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St John's Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks or 5 terminal half-lives (t½; whichever is longer) prior to first study treatment administration.

  • Ongoing, recurrent, or chronic hypokalemia or hypomagnesemia.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Parexel International GmbH Berlin Germany 14050

Sponsors and Collaborators

  • Idorsia Pharmaceuticals Ltd.

Investigators

  • Study Director: Clinical Trials, Idorsia Pharmaceuticals Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Idorsia Pharmaceuticals Ltd.
ClinicalTrials.gov Identifier:
NCT03907215
Other Study ID Numbers:
  • ID-078-114
First Posted:
Apr 8, 2019
Last Update Posted:
Oct 31, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 31, 2019