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Also known as Movantik
Naloxegol · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fasted conditions |
| B | EXPERIMENTAL | Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation under fed conditions |
| C | EXPERIMENTAL | Naloxegol film-coated IR tablet 25 mg Phase III formulation under fasted conditions |
| Name | Type | Description |
|---|---|---|
| Naloxegol | DRUG | Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation |
| Diltiazem XR | DRUG | Oral 240mg tablet |
Inclusion Criteria: * Female non-pregnant, non-lactating. * Volunteers with suitable veins for cannulation or repeated venipuncture. * Male healthy volunteers should be willing to use barrier contraception ie, condoms, from the first day of dosing until 3 months after dosing with the investigationa...
Naloxegol is being studied for opioid induced constipation and drug induced constipation. It is a small molecule developed by AstraZeneca PLC (ticker AZN) and is currently in Phase 1 clinical development. The available trials enrolled healthy volunteers to evaluate its pharmacokinetics and bioequivalence.
Naloxegol targets OPRM1, the mu opioid receptor, and acts as an antagonist. By blocking this receptor, it is designed to counteract opioid-induced slowing of the gastrointestinal tract, which is the basis for its investigation in opioid induced constipation and drug induced constipation.
Naloxegol is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is responsible for the clinical program, including the Phase 1 trials conducted in the United Kingdom and the United States.
Naloxegol is in Phase 1 clinical development. It has completed one Phase 1 trial and is not approved for any indication. The program includes a completed bioequivalence study and a completed drug interaction study, both in healthy volunteers.
Naloxegol has been evaluated in two completed Phase 1 trials: NCT01623609, a bioequivalence study in healthy volunteers with opioid induced constipation, and NCT01594619, which investigated the effects of diltiazem on naloxegol pharmacokinetics in healthy volunteers with drug induced constipation.