Pharmacy / IMP Manual — GLPI103-301
| Field | Value |
|---|---|
| Document ID | TMF-PHARM |
| Version | 1.0 |
| Study No. | GLPI103-301 |
| Standard | ICH E6(R3); GMP; double-dummy blinding |
| Confidentiality | Confidential — TMF |
Instructions for handling the investigational medicinal products at site.
[MOCK]specifics.
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical Supply / Pharmacy | Initial IMP manual |
1. Products & Double-Dummy
| Kit | Contents |
|---|---|
| Arm A | GLPI-103 IV (active) + oral placebo |
| Arm B | GLPI-103 Oral (active) + IV placebo |
| Arm C | Oral semaglutide (active) + IV placebo |
All subjects receive one IV product + one oral product of identical appearance to maintain the blind. Kit assignment via IWRS (TMF-RAND).
2. Storage & Stability
Store per label (e.g., refrigerated 2–8 °C for IV; controlled room temperature for tablets); protect from light/moisture; restricted-access, temperature-monitored. Temperature excursions quarantined and reported to the sponsor for disposition (do not use until released).
3. Preparation & Administration
- IV: prepared by unblinded pharmacist per instructions; administered/observed at site weekly; infusion/injection details and in-use stability specified.
- Oral: dispensed for daily self-administration with dosing instructions (titration schedule per PROT-301 §6).
4. Dose Titration & Modification
Dispense the scheduled titration step (1→2→4 mg QW IV; 2→4→8 mg QD oral; 3→7→14 mg QD semaglutide). Dose delay/down-titration for intolerance per PROT-301 §6.2 (blinding maintained via IWRS kit changes).
5. Accountability, Returns & Destruction
Drug accountability logs maintained (received/dispensed/returned/destroyed); reconciled at monitoring visits; unused/expired IMP returned or destroyed per procedure with documentation. Compliance computed (pill count + IWRS); <80% / >120% flagged (PPS-relevant).
6. Blinding & Unblinding
Unblinded pharmacist prepares IV; blinded staff administer where required by design. Emergency unblinding via IWRS only, documented and reported (TMF-RAND §2).