HealthyPhase 1NCT03907215
A Clinical Study to Examine the Drug-drug Interactions Between ACT-541468 and Citalopram in Healthy Male and Female Subjects
A Phase 1 study testing ACT541468 and Citalopram in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
Trial summary
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects Read more about this study
- Who is it for?
- Ages 24 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ACT541468 and Citalopram
- 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
- 1 siteGermany
- Study dates
- 9 Apr 2019to 26 Jun 2019
- 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 24 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects
- Conditions
- Healthy
- Being tested
- ACT541468, ACT541468 placebo, Citalopram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT541468Drug
50 mg; film-coated tablet for oral use
ACT541468 placeboDrug
film-coated tablet for oral use
CitalopramDrug
20 mg; tablet tor oral use; for single- or repeated dosing
| Study group | Role | What they receive |
|---|---|---|
| Treatment A and B | Other | 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. Receives: Drug: ACT541468; Drug: ACT541468 placebo |
| Treatment C, D, E, and F | Other | 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. Receives: Drug: ACT541468; Drug: ACT541468 placebo; Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation
Measured: From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start9 Apr 2019
- Primary completion26 Jun 2019
- Study completion26 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-center, single-blind, randomized, placebo-controlled, sequential design Phase 1 study with the inclusion of two double-blind nested crossover parts
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Idorsia Pharmaceuticals Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907215
- Sponsor's protocol ID
- ID-078-114
- Status last verified
- Oct 2019
- First submitted
- 21 Mar 2019
- Last updated
- 31 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03907215
- Acronym / sponsor ID
- ID-078-114
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Idorsia Pharmaceuticals Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 8 Apr 2019 (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.
A clinical study to examine the drug-drug interactions between ACT-541468 and citalopram in healthy male and female subjects
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single-center, single-blind, randomized, placebo-controlled, sequential design Phase 1 study with the inclusion of two double-blind nested crossover parts
| Arm | Type | Receives |
|---|---|---|
| Treatment A and B | Other | Drug: ACT541468, Drug: ACT541468 placeboOn 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. |
| Treatment C, D, E, and F | Other | Drug: ACT541468, Drug: ACT541468 placebo, Drug: CitalopramFrom 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. |
Who may qualify
- Ages
- 24 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (12 listed)
- 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).
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 |
|---|---|---|
| ACT54146850 mg; film-coated tablet for oral use | Drug | Treatment A and B, Treatment C, D, E, and F |
| ACT541468 placebofilm-coated tablet for oral use | Drug | Treatment A and B, Treatment C, D, E, and F |
| Citalopram20 mg; tablet tor oral use; for single- or repeated dosing | Drug | Treatment C, D, E, and F |
Primary outcome
Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation
Time frame: From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10
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 31 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Clinical Trials study director
Idorsia Pharmaceuticals Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ACT541468 and Citalopram in people with Healthy, run by Idorsia Pharmaceuticals Ltd. at 1 site in Germany.
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 6 inclusion and 12 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 31 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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?
Change from baseline for Saccadic Peak Velocity (degrees/sec) to assess sedation (time frame: From pre-dose to 8 hours after dosing on Day 1, Day 2, Day 3, Day 9, and Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2019.