NCT01311882 is a Phase 1 clinical trial of MK-4305 40 mg in Insomnia, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT01311882?

NCT01311882 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT01311882?

Interventions in NCT01311882: MK-4305 40 mg, MK-4305 20 mg, Zopiclone, Grossly Matching Placebo for Zopiclone, Matching Placebo for MK-4305.

Is NCT01311882 still recruiting?

NCT01311882 is currently completed. Last updated 19 February 2016.

Last reviewed 2016-02-19 · How we verify

NCT01311882

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multiple Dose Study to Evaluate Next Day Effects of MK-4305 on Driving Performance in Healthy Non-Elderly Subjects

Completed Phase 1 Last updated 19 February 2016

What this trial tests

Phase 1 trial testing MK-4305 40 mg in Insomnia in 28 participants. Completed in 1 November 2011.

Timeline

1 April 2011

Primary endpoint
1 November 2011

1 November 2011

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	28
Start date	1 April 2011
Primary completion	1 November 2011
Estimated completion	1 November 2011
Sites	1 location across Netherlands

Drugs / interventions tested

MK-4305 40 mg — full drug profile →
MK-4305 20 mg — full drug profile →
Zopiclone (ZOPICLONE) — full drug profile →
Grossly Matching Placebo for Zopiclone — full drug profile →
Matching Placebo for MK-4305 — full drug profile →

Conditions studied

Insomnia — all drugs for Insomnia →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 21 to 64, any sex, with Insomnia. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean differences of standard deviation of lateral position (SDLP) on highway driving between MK-4305 and placebo
Time frame: Day 2

Sponsor's own description

This is a study to evaluate next-day residual effects of MK-4305 on highway driving performance in healthy, non-elderly participants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

On-the-Road Driving Performance the Morning after Bedtime Use of Suvorexant 20 and 40 mg: A Study in Non-Elderly Healthy Volunteers.
Vermeeren A, Sun H, Vuurman EF, Jongen S, et al · · 2015 · cited 53× · PMID 26039969 · DOI 10.5665/sleep.5168

Verify or expand the search:

Other recruiting trials for Insomnia

Currently open trials in the same condition.

NCT07384429 — Effects of Lemborexant on Motor-sleep Comorbidity in Parkinson's Disease · Phase 4 · recruiting
NCT07270406 — Healthy Behaviors for Insomnia Prevention in People With HIV and Ongoing Pain · NA · recruiting
NCT07071324 — CF Wellness Program · NA · recruiting
NCT07417813 — A Multicenter Observational Study of Lemborexant on Insomnia Patients With Psychiatric Disorders · recruiting
NCT06348082 — Project Women's Insomnia Sleep Health Equity Study (WISHES) · NA · recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01311882 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 19 February 2016

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/NCT01311882.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing