Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06146101 | RePOSA-Revealing the Efficacy of IHL-42X Use in Patients With OSA | PHASE2 | ACTIVE NOT_RECRUITING | 560 | — | — | May 2, 2024 | Dec 1, 2026 | Apr 20, 2025 | 20 | United States |
| NCT05857384 | Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs | PHASE1 | COMPLETED | 125 | — | — | Sep 8, 2023 | Jul 31, 2024 | Jan 17, 2025 | 4 | Australia |
Phase 2 - Assess the change in AHI compared to baseline
Assess the proportion of IHL-42X that is taken up and enters the circulation post dose.
Compare the proportion of IHL-42X taken up and enters the circulation to the reference listed drugs for dronabinol and acetazolamide. It will be determined whereby 90% confidence interval for the ratio of averages of measures Cmax and AUC0-inf for IHL-42X and the reference listed drug.
Assess the effect of food on the uptake and absorption of IHL-42X by measuring Cmax (Maximum observed drug concentration)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring Tmax (time of the maximum drug concentration)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-last (Area under the drug concentration-time curve, from time zero to time of last measurable concentration)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-inf (Area under the drug concentration-time curve from time zero to infinity)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-12h (Area under the drug concentration-time curve from time zero to 12 hours)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring AUC0-24h (Area under the drug concentration-time curve from time zero to 24 hours)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring t1/2 (the elimination half-life)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring kel (Terminal elimination rate constant)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring CL/F (Apparent total body clearance)
Assess the effect of food on the uptake and absorption of IHL-42X by measuring Vz/F (Apparent volume of distribution)
| Arm | Type | Description |
|---|---|---|
| Phase 2 Investigational Product - IHL-42X Low dose | EXPERIMENTAL | IHL-42X (2.5 mg dronabinol + 125 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| Phase 2 Investigational Product - IHL-42X High dose | EXPERIMENTAL | IHL-42X (5 mg dronabinol + 250 mg acetazolamide), one capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| Phase 2 Placebo | PLACEBO_COMPARATOR | One capsule self-administered once daily every night approximately 1 hour prior to bed for 4 weeks. |
| Phase 3 Investigational Product - IHL-42X | EXPERIMENTAL | IHL-42X (dose will be identified based on the safety and efficacy results in Phase II), one capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks. |
| Phase 3 Comparator - Reference Listed Drug/Dronabinol | ACTIVE_COMPARATOR | One capsule of dronabinol (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months. |
| Phase 3 Comparator - Reference Listed Drug/Acetazolamide | ACTIVE_COMPARATOR | One capsule of acetazolamide (equivalent dose strength to that in the IHL-42X optimal dose strength) self-administered once daily every night approximately 1 hour prior to bed for 3 months then IHL-42X (optimal dose) one capsule self-administered once daily every night approximately 1 hour prior to bed for the remaining 9 months. |
| Phase 3 Placebo | PLACEBO_COMPARATOR | One capsule self-administered once daily every night approximately 1 hour prior to bed for 52 weeks. |
| Comparator Arm A- Reference Listed Drug/Marinol | ACTIVE_COMPARATOR | dronabinol 5 mg, two capsules of 2.5 mg administered on an empty stomach once only in the study period |
| Comparator Arm B-Reference Listed Drug/Taro Acetazolamide | ACTIVE_COMPARATOR | 250 mg acetazolamide, one tablet administered on an empty stomach once only in the study period |
| Investigational Product Arm C-IHL42X Fasted | EXPERIMENTAL | IHL-42X (5 mg dronabinol, 250 mg acetazolamide), one capsule administered on an empty stomach once only in the study period |
| Investigational Product Arm D-IHL42X Fed | EXPERIMENTAL | IHL-42X (5 mg dronabinol, 250 mg acetazolamide), one capsule administered after food once only in the study period |
| Name | Type | Description |
|---|---|---|
| IHL-42X Low Dose | DRUG | Softgel capsule |
| IHL-42X High Dose | DRUG | Softgel capsule |
| Placebo | DRUG | Softgel capsule |
| IHL-42X (Optimal Dose) | DRUG | Softgel capsule |
| Dronabinol | DRUG | Softgel capsule |
| Acetazolamide | DRUG | Softgel capsule |
| IHL42X | DRUG | IHL-42X consists of acetazolamide and dronabinol. |
| Acetazolamide 250 MG | DRUG | A solid tablet containing 250 mg acetazolamide |
| Dronabinol 2.5 MG | DRUG | A soft gelatin capsules containing 2.5mg dronabinol |
Inclusion Criteria: 1. Aged ≥18 years of age 2. Screening polysomnography (PSG) findings confirmed on central over-read: 1. AHI ≥15 2. ≤ 25% central or mixed apneas/hypopneas 3. no Cheyne-Stokes respiration 4. total sleep time ≥ 2 hours 3. Intolerant, non-compliant, or naïve to PAP (No...