DReAMzz- Dronabinol and Acetazolamide Medication for Sleep Apnea (ZZ). Dose Confirmation Crossover Study for IHL-42X in Subjects With Obstructive Sleep Apnea.

Conditions

• Obstructive Sleep Apnea (OSA)

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 1
• IHL-42X: 5 mg dronabinol + 125 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 2
• IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 3
• IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 4
• IHL-42X: 5 mg dronabinol + 250 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 5
• IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 6
• IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 7
• IHL-42X: 5 mg dronabinol + 375 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 8
• IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide — DRUG
  DReAMzz Phase 2 Investigational Product - IHL-42X Dose 9
• Placebo: Negative control — DRUG
  DReAMzz Phase 2 Placebo

Study Details

The goal of this randomized, double-blind, multi-dose crossover clinical trial is to determine the safety and efficacy of IHL-42X in subjects with obstructive sleep apnea. The primary endpoint is: Change in AHI4 at the end of each treatment period compared to baseline (each treatment period is 28 days). The study will consist of three separate four-way crossover dose-comparison studies each comparing three dose strengths of IHL-42X to placebo. The double-blind four-way crossover will be conducted according to a Williams design. Each of the crossover studies will test different doses of dronabinol in combination with a distinct, set dose of acetazolamide. In total, nine different combinations of dronabinol and acetazolamide formulated as IHL-42X will be tested in the study. The optimal dose strength will be selected based on safety and efficacy over a 4-week treatment period.

Key Dates

Start date

Jun 30, 2026

Status verified

Jun 2026

Primary completion

Apr 30, 2027

Completion

May 31, 2027

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: IHL-42X: 2.5 mg dronabinol + 125 mg acetazolamide
  IHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 5 mg dronabinol + 125 mg acetazolamide
  IHL-42X (5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 7.5 mg dronabinol + 125 mg acetazolamide
  IHL-42X (7.5 mg dronabinol + 125 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 2.5 mg dronabinol + 250 mg acetazolamide
  IHL-42X (2.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 5 mg dronabinol + 250 mg acetazolamide
  IHL-42X (5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 7.5 mg dronabinol + 250 mg acetazolamide
  IHL-42X (7.5 mg dronabinol + 250 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 2.5 mg dronabinol + 375 mg acetazolamide
  IHL-42X (2.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 5 mg dronabinol + 375 mg acetazolamide
  IHL-42X (5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Experimental: IHL-42X: 7.5 mg dronabinol + 375 mg acetazolamide
  IHL-42X (7.5 mg dronabinol + 375 mg acetazolamide), self-administered once daily every night approximately 1 hour prior to bed for 4 weeks.
• Placebo Comparator: Placebo: Negative control
  One capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks

Primary Outcome Measure

Change in AHI4 at the end of each treatment period compared to baseline [ Time Frame: Each treatment period (28 days) ]

Central Contacts

• Mark Bleackley
  +61 2 9634 4508
  [email protected]
• Pia Kroner
  +61 (2) 9634 4508
  [email protected]

Locations (14)

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