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TrIP-2D · 1 trial · 1 indication
Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. The dosing formulations were as follows: Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate) FEV1 (L)was measured at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours postdose.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Represents Dose A in the Dosing Sequence assignments. |
| TrIP-2D (100mcg) | EXPERIMENTAL | Represents Dose B |
| TrIP-2SS (100mcg) | EXPERIMENTAL | Represents Dose C |
| TrIP-2D (400mcg) | EXPERIMENTAL | Represents Dose D |
| TrIP-2SS (100mcg) + Foradil (12mcg) | EXPERIMENTAL | Represents Dose E. All subjects received Dose E as their final (5th) dose, after completing their initial 4 single doses according to their sequence assignment. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Supplied as an empty size-2 capsule and administered as a single dose via C2S inhaler. |
| TrIP-2D | DRUG | Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. |
| TrIP-2SS | DRUG | Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. |
| TrIP-2SS + Foradil | DRUG | Trospium inhalation powder containing 100 mcg TrCl (trospium chloride), plus foradil (12 mcg formoterol fumarate) supplied as dry powder in size-2 capsules and administered as a single dose via C2S inhaler. |
Inclusion Criteria: * Male or female COPD subjects between the ages of 40 and 80 years * Body mass index between 18 and 35 * Medically healthy (other than COPD) * FEV1/FVC less than or equal to 0.70 * Current non-smoker or able to abstain from smoking for at least 8 hours postdose * Within the prev...
TrIP-2D is an investigational small molecule being developed for the treatment of Chronic Obstructive Pulmonary Disease (COPD). It is administered as an inhalation powder. The drug is currently in clinical development and has not been approved by regulatory authorities.
TrIP-2D is being developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALKS. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for COPD.
TrIP-2D is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The Phase 2 trial has been completed, and the drug remains under evaluation for its potential use in treating COPD.
TrIP-2D has one completed Phase 2 clinical trial, identified as NCT00801684, titled "ALK27-001: A Study of Trospium Inhalation Powder (TrIP) Administered to Subjects With COPD." This randomized, double-blind, placebo-controlled study enrolled 24 participants in the United States.
TrIP-2D is also known as Trospium Inhalation Powder (TrIP). The clinical trial NCT00801684 refers to the drug as TrIP, and it is being studied for the treatment of Chronic Obstructive Pulmonary Disease (COPD).