Study to Evaluate the Abuse Potential of ACT-541468 in Healthy Recreational Drug Users

Sponsor

Idorsia Pharmaceuticals Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03657355

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

31.5

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This placebo- and active controlled study will investigate the abuse potential of ACT-541468 in healthy recreational drug users

Condition or Disease	Intervention/Treatment	Phase
Healthy Recreational Drug Users	Drug: ACT-541468 Drug: Suvorexant Drug: Zolpidem Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

63 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Single-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 6-way cross-over studySingle-center, randomized, double-blind, double-dummy, placebo- and active-controlled, 6-way cross-over study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

For blinding purposes, suvorexant and zolpidem will be over-encapsulated, whereas a matching-placebo will be used for ACT-541468.

Primary Purpose:

Treatment

Official Title:

Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, 6-way Cross-over Study to Evaluate the Abuse Potential of Single, Oral Doses of ACT-541468 in Healthy Recreational Drug Users

Actual Study Start Date :

Sep 7, 2018

Actual Primary Completion Date :

Aug 8, 2019

Actual Study Completion Date :

Aug 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 50 mg ACT-541468 ACT-541468 will be administered as tablets for oral use.	Drug: ACT-541468 ACT-541468 will be administered as 50 mg tablets for oral use.
Experimental: 100 mg ACT-541468 ACT-541468 will be administered as tablets for oral use.	Drug: ACT-541468 ACT-541468 will be administered as 50 mg tablets for oral use.
Experimental: 150 mg ACT-541468 ACT-541468 will be administered as tablets for oral use.	Drug: ACT-541468 ACT-541468 will be administered as 50 mg tablets for oral use.
Active Comparator: 150 mg suvorexant Suvorexant will be administered as tablets for oral use.	Drug: Suvorexant Suvorexant will be administered as 15 mg over-encapsulated tablets for oral use.
Active Comparator: 30 mg zolpidem Zolpidem will be administered as tablets for oral use.	Drug: Zolpidem Zolpidem will be administered as 10 mg over-encapsulated tablets for oral use.
Placebo Comparator: Placebo Placebo will be administered as tablets for oral use.	Drug: Placebo Matching-placebo will be used.

Outcome Measures

Primary Outcome Measures

Maximum effect (Emax) of the Drug Liking VAS ('at this moment') over 24 h post-dose during each treatment period [Duration: for up to 24 hours post-dose]
VAS = visual analogue scale

Secondary Outcome Measures

Drug Liking VAS (bipolar) [Duration: for up to 24 hours post-dose]
VAS = visual analogue scale
Overall Drug Liking VAS (bipolar) [Duration: for up to 12 hours post-dose]
VAS = visual analogue scale
Take Drug Again VAS (bipolar) [Duration: for up to 12 hours post-dose]
Good Effects VAS (unipolar) [Duration: for up to 24 hours post-dose]
Drug Similarity VAS [Duration: for up to 1 hour post-dose]
VAS = visual analogue scale
Bad Effects VAS (unipolar) [Duration: for up to 24 hours post-dose]
VAS = visual analogue scale
Alertness/Drowsiness VAS (bipolar) [Duration: for up to 24 hours post-dose]
VAS = visual analogue scale
Any Effects VAS (unipolar) [Duration: for up to 24 hours post-dose]
VAS = visual analogue scale
Feeling High VAS (unipolar) [Duration: for up to 24 hours post-dose]
VAS = visual analogue scale
Bowdle VAS Internal and External Perceptions [Duration: for up to 24 hours post-dose]
Observer's Assessment of Alertness/Sedation composite and sum scores [Duration: for up to 24 hours post-dose]
Reaction time task score [Duration: for up to 8 hours post-dose]
Rapid visual information processing score [Duration: for up to 8 hours post-dose]
Paired Associates Learning score [Duration: for up to 8 hours post-dose]

Other Outcome Measures

AUC(0-t) of ACT-541468 [Duration: for up to 24 hours post-dose]
AUC(0-∞) of ACT-541468 [Duration: for up to 24 hours post-dose]
Cmax of ACT-541468 [Duration: for up to 24 hours post-dose]
tmax of ACT-541468 [Duration: for up to 24 hours post-dose]
t½ of ACT-541468 [Duration: for up to 24 hours post-dose]
Treatment-emergent adverse events (AEs) [All AEs from (first) admittance on Day -1 up to EOS, i.e. for up to 9 weeks]
Treatment-emergent serious AEs (SAEs) [SAE reporting: from signature of informed consent up to EOS, i.e. for up to 13 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Signed informed consent prior to any study-mandated procedure
Male or female healthy subjects, 18-55 years of age (inclusive) at Screening
Body mass index of 18.0-33.0 kg/m2 (inclusive) at Screening and a minimum weight of 50.0 kg at Screening
Current sedative users who have used sedatives (e.g., benzodiazepines, zolpidem, eszopiclone, gamma-hydroxybutyrate, barbiturates) for recreational (non-therapeutic) purposes (i.e., for psychoactive effects) at least ten times in their life and at least once in the 12 weeks before Screening
Women of childbearing potential must consistently and correctly use a reliable method of contraception with a failure rate of < 1% per year, be sexually inactive, or have a vasectomized partner
Women of non-childbearing potential
Male subjects are required to use a medically acceptable method of contraception throughout the entire study period and for at least 90 days after last study drug administration

Exclusion Criteria:

History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment(s)
Positive HIV or hepatitis B/C test at Screening
Female subjects who are currently pregnant or lactating or who are planning to become pregnant within 1 month of the last study treatment administration
Modified Swiss Narcolepsy Scale total score < 0 at Screening or history of narcolepsy or cataplexy
Substance or alcohol dependence within 2 years prior to Screening or prior participation in a substance or alcohol dependence rehabilitation program
Subjects who have a positive urine drug screen at admittance to the qualification or core phase
Any sleep-disorder including self-reported insomnia disorder, breathing-related sleep disorders, restless legs syndrome (RLS), nightmare disorder, non-rapid eye movement (REM), sleep arousal disorders, REM sleep behavior disorder, circadian rhythm sleep-wake disorders, or narcolepsy
Any of the following SLEEP-50 Questionnaire scores at Screening:
≥ 15 on Apnea subscale;
≥ 7 on Narcolepsy subscale;
≥ 7 on RLS or Periodic limb movement disorder subscale;
≥ 8 on Circadian Rhythm subscale;
≥ 7 on Sleepwalking subscale;
≥ 3 on Item 32 and ≥ 9 on Items 33 to 35 (i.e., on nightmare subscale);
≥ 15 on Impact subscale.
Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Altasciences Clinical Kansas, Inc. (former Vince and Associates Clinical Research, Inc.)	Overland Park	Kansas	United States	66212
2	Altasciences Company Inc.	Montreal		Canada	H3P 3P1

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:

NCT03657355

Other Study ID Numbers:

ID-078-107

First Posted:

Sep 5, 2018

Last Update Posted:

Sep 19, 2019

Last Verified:

Sep 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Zolpidem

Suvorexant

Study Results

No Results Posted as of Sep 19, 2019