A Phase 2a, Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ORX750 in Subjects with Narcolepsy and Idiopathic Hypersomnia – (CRYSTAL-1)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Centessa Pharmaceuticals UK Limited
- Enrollment
- 96
- Locations
- 27
- Primary Endpoint
- Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief Summary
To evaluate the safety and tolerability of ORX750
Investigators
Senior Vice President, Clinical Development
Scientific
Centessa Pharmaceuticals UK Limited
Eligibility Criteria
Inclusion Criteria
- •18-65 years of age
- •BMI ≥17 and ≤37 kg/m2
- •Meets the diagnostic criteria of Narcolepsy Type 1 (NT1), Type 2 (NT2) or Idiopathic Hypersomnia (IH) according to ICSD-3-TR criteria
- •Is willing and able to discontinue all medications used for the treatment of narcolepsy or idiopathic hypersomnia
- •Is willing and able to adhere to additional protocol requirements
Exclusion Criteria
- •A medical disorder other than NT1, NT2, or IH that is associated with excessive daytime sleepiness (EDS).
- •Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease
Outcomes
Primary Outcomes
Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.
Safety and Tolerability-incidence, severity, and causal relationship of TEAEs, including serious TEAEs; changes from baseline in laboratory tests (including biochemistry, haematology, and urinalysis), vital signs, weight, and 12-lead ECGs; and C-SSRS scores following treatment with ORX750 versus treatment with placebo.
Secondary Outcomes
- PK-Day 1: Cmax, tmax, and AUC0-last; Days 14 and 28: Cmax,ss, tmax, and AUCτ, and other PK parameters as appropriate.
- PD-mean sleep latency (average of the first 4 trials) in the MWT for ORX750 versus placebo and subjective daytime sleepiness using the ESS, including change from baseline to specified postdose time points.